United States Prevention, Pesticides EPA738-R-00-019
Environmental Protection And Toxic Substances September 2000
Agency (7508C)
4>EPA Reregistration
Eligibility Decision (RED)
Etridiazole (Terrazole®)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
. WASHINGTON, D.C. 20460
3
"\, tffF' OFFICE OF
PRO PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
December 4, 2000
RE: Reregistration Eligibility Decision for Etridiazole (Terrazole®)
Dear Recipient:
Attached is the Reregistration Eligibility Decision for Etridiazole (Terrazole®). You will note
that in the text of the document, vapor pressure of the dry formulations is identified as a data gap.
However, the Agency has reevaluated the need for this data in light of other data that are being
requested, and decided not to require the vapor pressure study. Consequently, vapor pressure
data are not listed in the accompanying Data Call-In.
If you have any questions, please free to contact me at 703/308-8065.
Sincerely,
Lois Rossi, Director
Special Review and Reregistration Division
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Page 56 of Human Health Risk Assessment
As etridiazole is used only as a soil-incorporated fungicide and seed treatment, there are a limited
number of use patterns. It is used for at-planting in-furrow crop soil treatments (only cotton at
this time); as a soil treatment, either by drenching or addition to potting soil, for ornamentals and
interiorscapes; on ornamental turf and golf course fairways, greens, and tees, either by spray or
broadcast application; and as a seed treatment, applied in either large commercial facilities, or at
the farm. Total annual use of etridiazole is estimated by BEAD at approximately 75,000 Ib ai
(these estimates are approximate and therefore totals by crop may not exactly concur with overall
total cited). An estimated 42,500 Ibs ai of etridiazole is applied to cotton at planting, with a
typical application rate of about 0.17 Ibs ai/acre. About 28,000 Ibs ai of etridiazole are believed to
be applied by nurseries; mainly to control for root diseases (USDA, NAPIAP Report, l-CA-96).
About 5,000 Ibs ai of etridiazole are also applied annually to golf courses. All of the dusts are
formulated by one company, Gustafson, for seed treatment. Only a limited amount of seed
treatment (less than 1% of the market per BEAD) is done in this country using this active
ingredient, but all active labels are evaluated for handler and post-application health risks.
Etridiazole is registered for use as a seed treatment on barley, beans/peas, peanuts, corn,
safflower, sorghum, soybeans and wheat; of these crops, peanuts have received a modest amount
of treatments with etridiazole.
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£ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
* WASHINGTON, D.C. 20460
'D
V
"/
f^' ' ~"f"° OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or the
Agency) has completed its review of the available data and public comments received related to the
risk assessment for the thiazole pesticide etridiazole (Terrazole®). Based on its review, EPA has
identified risk mitigation measures that the Agency believes are necessary to address the human health
and environmental risks associated with the current use of etridiazole. The EPA is now publishing its
reregistration eligibility, risk management, and tolerance reassessment decisions for the current uses of
etridiazole, and its associated human health and environmental risks. The enclosed "Reregistration
Eligibility Decision for Etridiazole," which was approved on September 27, 2000, contains the
Agency's decision on the individual chemical etridiazole.
A Notice of Availability for this Reregistration Eligibility Decision (RED) for etridiazole is published in
the Federal Register. To obtain a copy of the RED document, please contact the OPP Public
Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200 Pennsylvania Avenue NW,
Washington, DC 20460, telephone (703) 305-5805. Electronic copies of the RED and all supporting
documents are available on the Internet. See http:www.epa.gov/pesticides.
This document and the process used to develop it are the result of a pilot process to facilitate greater
public involvement and participation in the reregistration and/or tolerance reassessment decisions for
pesticides. As part of the Agency's effort to involve the public in the implementation of the Food
Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to maintain open
public dockets and to engage the public in the reregistration and tolerance reassessment processes for
these chemicals. The U.S. Department of Agriculture held a teleconference on May 11, 2000, with
interested stakeholders and provided the Agency with input on etridiazole usage and occupational
practices. The human health and environmental risk assessments were placed in the public docket and
an invitation for public comment was announced in the Federal Register on June 28, 2000. In
addition, a second conference call was held September 13, 2000 during which the Agency presented a
summary of the risk assessment and the results of the risk management decision for the registrants,
USD A, and other stakeholders.
Please note that the etridiazole risk assessment and the attached RED concern only this particular
chemical. Etridiazole is a member of the thiazole class of fungicides. While current data are limited,
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EPA has evidence that compounds within a class may share a common mechanism of toxicity. At this
time, the Agency does not have sufficient data concerning common mechanism issues to determine
whether or not etridiazole shares a common mechanism of toxicity with other substances, including
other thiazoles or other probable human carcinogens. Therefore, for the purposes of this risk
assessment, the Agency has assumed that etridiazole does not share a common mechanism of toxicity
with any other chemicals.
End-use product labels should be revised by the manufacturer to adopt the changes set forth in Section
V of this document. Instructions for registrants on submitting revised labeling and the time frame
established to do so can be found in Section V of this document.
If you have questions on this document or the proposed label changes, please contact the Special
Review and Reregistration Division representative, Robbi Farrell, at (703) 308-8065. For questions
about product reregistration and/or the Product DCI that accompanies this document, please contact
Venus Eagle at 703/308-8045.
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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Reregistration Eligibility Decision
for
Etridiazole
List A
Case 0009
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Table of Contents
Glossary of Terms and Abbreviations iii
Executive Summary v
I. Introduction 1
II. Chemical Overview 2
A. Chemical Identification 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Regulatory History 5
III. Summary of Etridiazole Risk Assessment 6
A. Human Health Risk Assessment 6
1. Toxicity of Etridiazole 6
2. Dietary Toxicity 7
a. Acute Dietary Endpoint 8
b. Chronic (Non-Cancer) Dietary Endpoint 9
c. Chronic (Cancer) Dietary Endpoint 9
3. FQPA Safety Factor 9
4. Hazard Determination 10
5. Exposure Assumptions 11
6. Dietary (Food) Risk Assessment 11
a. Acute Dietary Risk 11
b. Chronic (Non-Cancer) Dietary Risk 12
c. Chronic (Cancer) Dietary Risk 13
7. Dietary Risk from Drinking Water 13
a. Surface Water 14
b. Ground Water 15
8. Residential and Other Non-Occupational Risk 16
9. Aggregate Risk 17
a. Acute Aggregate Risk 17
b. Short-Term Aggregate Risk 18
c. Chronic (Non-Cancer) Aggregate 18
d. Chronic (Cancer) Aggregate 18
10. Occupational Risk 19
a. Occupational Toxicity 19
b. Occupational Exposure 22
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c. Handler Risks 23
d. Incident Reports 35
B. Environmental Risk Assessment 35
1. Fate and Transport 35
2. Water Resources 37
3. Ecological Risks 37
a. Risks to Birds 37
b. Risks to Mammals 38
c. Risks to Fish and Aquatic Invertebrates 38
d. Risks to Aquatic Plants 39
e. Risks to Endangered Species 39
IV. Risk Management, Reregistration and Tolerance Reassessment Decision 39
A. Determination of Reregistration Eligibility 39
B. Tolerance Reassessment 40
C. Regulatory Position 40
1. Food Quality Protection Act Findings 40
a. Determination of Safety for U.S. Population 40
b. Determination of Safety for Infants and Children 41
c. Endocrine Disrupter Effects 42
d. Cumulative Risks 42
D. Tolerance Summary 43
1. Tolerances Listed Under 40 CFR §180.370 43
2. New Tolerances to Be Established under 40 CFR §180.370 44
3. Codex Harmonization 45
4. Residue Analytical Methods 46
E. Human Health Risk Mitigation 46
1. Dietary Mitigation 46
a. Acute Dietary (Food) 46
b. Chronic (Non-Cancer) Dietary (Food) 46
c. Cancer Dietary (Food) 47
d. Dietary (Drinking Water) 47
2. Non-occupational Risk Mitigation 48
a. Non-occupational Non-cancer Risk 48
b. Non-occupational Cancer Risk 49
3. Aggregate Risk Mitigation 49
a. Acute Aggregate Risk 49
b. Short-term Aggregate Risk 49
c. Chronic (Non-Cancer) Aggregate Risk 50
d. Chronic Cancer Aggregate Risk 50
4. Occupational Risk Mitigation 51
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a. Handler Exposure 51
b. Post-Application Exposure 55
c. Dermal and Inhalation Toxicity and Exposure Uncertainties . . 56
5. Environmental Risk Mitigation 56
a. Birds 56
b. Mammals 57
c. Fish and Aquatic Invertebrates 57
d. Aquatic Plants 58
e. Summary of Environmental Risk Mitigation 58
F. Other Label Statements 58
1. Endangered Species Statement 59
2. Spray Drift Management 59
3. For Commercial Use Only 59
V. Actions Required of Registrants 60
A. Manufacturing Use Products 60
1. Water Exposure Data Requirements 60
2. Additional Generic Data Requirements 60
3. Labeling for Manufacturing Use Products 62
B. End-Use Products 62
1. Additional Product-Specific Data Requirements 62
2. Labeling for End-Use Products 63
C. Labeling Changes Summary Table 64
D. Existing Stocks 74
VI. Appendices 76
Appendix A. Use Patterns Eligible for Reregistration 77
Appendix B. Data Supporting Guideline Requirements for the Reregistration of
Etridiazole 82
Appendix C. Technical Support Documents 89
Appendix D. Citations Considered to Be Part of the Data Base Supporting the
Reregistration Eligibility Decision (Bibliography) 90
Appendix E. Generic Data Call-In 105
Appendix F. Product-Specific Data Call-In 109
Appendix G. EPA's Batching of Etridiazole Products for Meeting Acute Toxicity
Data Requirements for Reregistration 115
Appendix H. List of Registrants Sent This Data Call-In Notice 119
Appendix I. Electronically Available Forms 121
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Etridiazole Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Biological and Economic Analysis Division
Tara Chand-Goyal Antimicrobials & Plant Pathogens Branch
Steven Nako Economic Analysis Branch
Douglas Sellers Scientific Information & Analysis Branch
Environmental Fate and Effects Division
Thomas Steeger Environmental Risk Branch 4
Jose Melendez Environmental Risk Branch 4
Richard Lee Environmental Risk Branch 4
Dana Spatz Environmental Risk Branch 4
Health Effects Division
Danette Drew Reregistration Branch 3
Gary Bangs Reregistration Branch 3
Michelle Centra Reregistration Branch 3
Jess Rowland Reregistration Branch 3
Registration Division
Mary Waller Fungicide Branch
Summer Gardner-Jenkins Fungicide Branch
Special Review and Reregistration Division
Robbi Farrell Reregistration Branch 2
Richard Dumas Reregistration Branch 2
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Glossary of Terms and Abbreviations
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
BCF Bioconcentration Factor
CFR Code of Federal Regulations
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration.
EP End-Use Product
EPA Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLN Guideline Number
HAFT Highest Average Field Trial
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LOC Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MUP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
NA Not Applicable
NAWQA USGS National Water Quality Assessment
NPDES National Pollutant Discharge Elimination System
111
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Glossary of Terms and Abbreviations
NR Not Required
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PCA Percent Crop Area
PAD Population Adjusted Dose
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRZM/EXAMS Tier II Surface Water Computer Model
Qj* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RAC Raw Agriculture Commodity
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
SCI-GROW Tier I Ground Water Computer Model
SAP Science Advisory Panel
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TGAI Technical Grade Active Ingredient
TRR Total Radioactive Residue
USDA United States Department of Agriculture
USGS United States Geological Survey
UF Uncertainty Factor
UV Ultraviolet
WPS Worker Protection Standard
IV
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Executive Summary
This document presents the Agency's decision regarding the reregistration eligibility of the registered
uses of etridiazole. This document also presents the Agency's tolerance reassessment decision for
etridiazole, which includes the consideration of risk to infants and children for any potential dietary,
drinking water, dermal, inhalation or oral exposures. The Agency made its reregistration eligibility
determination and tolerance reassessment decision based on the data required for reregistration, the
current guidelines for conducting acceptable studies to generate such data, and published scientific
literature. The Agency has found that most currently registered uses of etridiazole are eligible for
reregistration, provided specified changes are made to the label. Golf course fairway use will be
removed from product labels due to ecological and drinking water risks, pending submission and
evaluation of additional exposure and toxicity data.
Use Summary
Etridiazole is a fungicide registered for use as a seed treatment on the following crops: barley, beans,
corn, cotton, peanuts, peas, sorghum, soybeans, safflower, and wheat. It is also registered for use on
cotton for in-furrow application at planting, on ornamental plants and shrubs by horticultural nurseries,
on non-bearing citrus and non-bearing coffee, and for golf course fairways, tees and greens. In
addition, seven states hold Special Local Need [Section 24(c)] registrations for use on tobacco
transplants. There are no registered homeowner uses. EPA estimates that approximately 84,000
pounds of active ingredient are used annually, about 50% of which is applied to cotton, 25% used by
nurseries on ornamentals, and 5% applied to golf course turf.
Carcinogenicity Classification
Etridiazole is classified as a Group B2 carcinogen (probable human carcinogen), based on multiple
tumor types in the liver, bile duct, mammary gland, thyroid and testes in rats. The Agency utilized a
low-dose (Qi*) approach to characterize human cancer risk.
Dietary Risks
Acute, chronic and cancer dietary risk from food are not of concern. Acute and chronic (non-cancer)
risks from etridiazole in groundwater and surface water are also not of concern. Aggregating food and
water risks results in cancer risks from surface water that are of concern for the general population
based on modeled estimates of environmental concentrations of etridiazole in surface water from use on
golf course tees, greens and fairways.
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Worker Risks
Risks for occupational handlers of etridiazole are of concern for some scenarios. The Agency has risk
concerns for occupational handlers loading/applying liquid for commercial seed treatment,
loading/applying granules, mixing/loading/applying wettable powders, and dispersing granules by hand.
Short- and intermediate-term risks are of concern for these scenarios, as are cancer risks. Long-term
handler exposures are not expected. In some cases, the calculated risks can be mitigated with
additional protective measures such as engineering controls. However, for some scenarios, engineering
controls are not feasible.
Occupational postapplication scenarios assessed for etridiazole include greenhouse or nursery workers
handling treated potting soil, golf course workers engaged in turf maintenance, and farmers handling
treated seed for planting. Postapplication exposure to etridiazole during harvesting or other late-season
activity is not expected since it is applied to cotton in-furrow only at the time of planting. There is
potential for short- and intermediate-term postapplication exposure to etridiazole residues for workers
involved in turf maintenance, handling treated seed, and handling treated potting soil. Long-term
postapplication exposure could occur for greenhouse/nursery workers handling treated potting soil.
The only postapplication exposure scenario with risks of concern to the Agency is handling treated
potting soil, which has cancer risks of 2.9 x 10"5 after 12 hours, which is the current restricted entry
interval (RET).
Non-occupational Risks
The only exposure scenario for non-occupational risk is exposure of golfers to treated golf course turf.
Due to the volatility of etridiazole, this exposure is expected to be negligible.
Ecological Risks
Etridiazole use on golf course turf is a concern given the relatively high application rates for turf and the
likelihood of golf course runoff to move toward surface water.
Acute risks for birds, mammals, fish, aquatic invertebrates and aquatic plants at the typical application
rates for golf course turf are of concern. Chronic risks are a concern for birds and aquatic organisms at
the typical application rate for turf. Chronic effects seen in laboratory studies include significant
reproductive effects in birds and limited growth in fish. No acceptable chronic mammalian data were
available, so chronic risks for mammals could not be assessed. Available data indicate that the
degradate 3-dichloromethyl-5-ethoxy-l,2,4-thiadiazole (3-DCMT) is highly toxic to aquatic organisms.
VI
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Cumulative Risk
FQPA requires that the Agency consider the cumulative effects of a particular pesticide's residues and
"other substances that have a common mechanism of toxicity." At this time, the Agency does not have
sufficient data concerning common mechanism issues to determine whether or not etridiazole shares a
common mechanism of toxicity with other substances, including other thiazoles or other probable human
carcinogens. Therefore, for the purposes of this risk assessment, the Agency has assumed that
etridiazole does not share a common mechanism of toxicity with any other chemicals.
More detailed information can be found in the technical supporting documents for etridiazole referenced
in this reregistration eligibility decision document. The revised risk assessments and related addenda
are not included in this document, but are available on the Agency's web page at
www.epa.gov/pesticides, and in the Public Docket.
Summary of Mitigation
To address drinking water risks associated with estimated surface water concentrations resulting from
the use of etridiazole on golf course tees, greens and fairways, the registrant has agreed to immediately
remove fairway use from product labels. The registrant has agreed to provide additional water data to
refine exposure estimates. In addition, a repeat cancer study in a second species is required to more
fully characterize carcinogenicity. Should either study result in estimates of risk greater than or equal to
those currently estimated, the registrant has agreed to voluntarily cancel the use on fairways. If the
additional water data and the second carcinogenicity study together result in risk estimates that are not
of concern, fairway use may be returned to product labels.
Pesticide handler risks will be mitigated by a combination of reduced rates and frequency of
application, increased personal protective equipment, use of engineering controls, deletion of some use
sites, cancellation of the flowable concentrate formulation, cancellation of the granular product
registered for golf course use, and elimination of several hand-held application methods. Specifically,
the registrants have agreed to the following mitigation measures:
1. Use on fairways will be removed from product labels immediately.
2. The maximum application rate, maximum amount applied per season and frequency of application
to golf course tees and greens will be reduced.
3. The granular formulation registered for use on golf course turf will be voluntarily cancelled.
4. Application by power dust blower, belly grinder, push-type spreader and by hand dispersal will be
deleted.
5. An organic-vapor respirator will be used for all handlers, except for in-furrow application to cotton
or when a closed system is used.
6. Closed systems will be used for seed treatment.
7. The dry flowable concentrate formulation will be voluntarily cancelled.
vii
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8. Application rates for treatment of potting soil with the granular formulation will be reduced.
In addition, confirmatory product chemistry, residue, toxicity, and exposure data are required.
vui
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to accelerate
the reregistration of products with active ingredients registered prior to November 1, 1984. The
amended Act calls for the development and submission of data to support the reregistration of an active
ingredient, as well as a review of all submitted data by the U.S. Environmental Protection Agency
(referred to as EPA or "the Agency"). Reregistration involves a thorough review of the scientific
database underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether or not the pesticide meets
the "no unreasonable adverse effects" criteria of FIFRA.
FQPA requires that the Agency consider the cumulative effects of a particular pesticide's residues and
"other substances that have a common mechanism of toxicity." The Agency is examining whether and
to what extent some or all organophosphorous and carbamate pesticides may share
acetylcholinesterase inhibition as a common mechanism of toxicity. Similarly, the Agency is examining
whether and to what extent some or all pesticides that may be carcinogens may also share a common
mechanism of toxicity. Current information on the common mechanism of toxicity for thiazoles is
limited, and the Agency's understanding of this relationship needs to be further developed. As a result,
the Agency has not determined if it would be appropriate to include them in a cumulative risk
assessment with other thiazoles or human carcinogen chemicals. Therefore, for the purposes of this
risk assessment, the Agency has assumed that etridiazole does not share a common mechanism of
toxicity with other thiazoles or human carcinogen chemicals.
This document presents the Agency's decision regarding the reregistration eligibility of the registered
uses of etridiazole, including the consideration of risk to infants and children for any potential food,
drinking water, dermal, inhalation or oral exposures, and cumulative effects as stipulated under the
FQPA for tolerance reassessment. In an effort to simplify the RED, the information presented herein is
summarized. More detailed information can be found in the technical supporting documents for
etridiazole referenced in this RED. The revised risk assessments and related addenda are not included
in this document, but are available on the Agency's web page at www.epa.gov/pesticides, and in the
Public Docket. The document consists of six sections. Section I is the introduction. Section n
provides a profile of the use and usage of etridiazole, and its regulatory history. Section m gives an
overview of the human health and environmental assessments, based on the data available to the
Agency. Section IV presents the reregistration eligibility and risk management decisions. Section V
summarizes the necessary label changes based on the risk mitigation measures outlined in Section IV.
Finally, the Appendices list all related documents and how to access them, and Data Call-In (DCI)
information.
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II. Chemical Overview
A. Chemical Identification
H5C2O
\
N
CCl
Etridiazole is a reddish-brown liquid with a boiling point of 95° C at 1 mm Hg, specific gravity of 1.5,
and octanol/water partition coefficient (Kow) of 2.344 x 103. Etridiazole has a water solubility of ~ 100
ppm at 25° C, and is soluble in acetone, carbon tetrachloride, ethanol, ether, and xylene. Etridiazole
hydrolyzes with acids and bases.
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Vapor Pressure:
Trade Name:
Basic Manufacturer:
B. Use Profile
Etridiazole
5-ethoxy-3-trichloromethyl-l,2,4-thiadiazole
Thiazole
2593-15-9
084701
C5H5C13N2OS
l.lxlO-2mmHgat25°C
Terrazole®, Banrot®, Koban®, Truban®, Terraclor®, 4-
Way®, Terra-Coat L-205-N®
Uniroyal Chemical Company
The following is information on the currently registered uses with an overview of use sites and
application methods. A detailed table of the uses of etridiazole eligible for reregistration is contained in
Appendix A.
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Type of Pesticide
Etridiazole is a soil fungicide.
Use Sites
Etridiazole is registered for use as a seed treatment on the following crops: barley, beans, corn, cotton,
peanuts, peas, sorghum, soybeans, safflower, and wheat. It is also registered for use on cotton for in-
furrow application at planting. In addition, etridiazole is registered for use on various ornamental plants
and shrubs by horticultural nurseries, non-bearing citrus, non-bearing coffee, and for golf course
fairways, tees and greens. Etridiazole is not registered for use on domestically grown tomatoes, but it is
used on imported tomatoes. There are no registered homeowner uses.
Seven states (Kentucky, Tennessee, North Carolina, South Carolina, Virginia, Ohio, and Indiana) hold
special local need registrations of Terrazole 35% Wettable Powder for use on tobacco. These
registrations were granted during the period March through June, 2000. Risks associated with this use
site have not been explicitly considered in this risk assessment and reregistration eligibility decision.
However, the Agency believes that the occupational risks from this use are within the range of those
considered in this risk assessment and are addressed by mitigation agreed upon by the registrant. This
use does not contribute to dietary exposure.
Target Pests
Damping-off, root rot, and stem rot caused by Pythium and Phytophthora
Formulation Types Registered
Etridiazole is formulated as dusts, granules, wettable powders, flowable concentrates and emulsifiable
concentrates. End-use products are sold in the U.S. under the trade names Terrazole®, Terraclor®,
Temik® Brand TSX, Banrot®, Koban®, PCNB+ Liquid Seed Treater®, 4-Way Peanut Seed
Protectant®, Terra-Coat® L-205N and Truban®.
The PCNB+®, 4-Way®, Terra-Coat®, Banrot® and Terraclor® products contain varying amounts of
PCNB, thiophanate-methyl, maneb, and captan. Furthermore, Temik® Brand TSX contains PCNB
and aldicarb; Terraclor SuperX® with Di-Syston® EC contains PCNB and disulfoton.
Method and Rates of Application
Mixing equipment for larger operations includes mechanically agitated tanks, and automated metered
pumps. For smaller operations, a seed box or hopper box may be used. Application equipment
includes planters with spray attachments, boom sprayers, smaller sprayers attached to tractors, all-
terrain vehicles or mowers, portable strap-on spreaders, push-type spreaders, hand dispersal, power
dust blowers, chemigation and low- or high-pressure hand-held spray wand.
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Use rates vary widely depending on the crop/target, as follows:
For in-furrow crop treatment: 0.13-0.38 Ibs ai/per acre (ai/A)
For soil drench treatment:
Typical: 6 oz. ai/1000 sq. ft. or 16.3 Ibs ai/A
Range (minimum and maximum label rates): 1.5 to 17.5 oz ai/1000 sq. ft. (4.1 to 47.6
Ibs ai/A)
For potting soil treatment: 1.1 oz ai/cubic yard (typical)
For golf course turf: 0.7 to 2.8 oz ai/1000 sq. ft. (1.9-7.6 Ibs ai/A) up to annual maximum total
of 19 Ibs ai/A
Seed treatment: 0.0078-0.0625 Ibs ai/100 Ibs seed
For tobacco transplant float beds: 0.7 oz. ai/100 gallons water
C. Estimated Usage of Pesticide
Table 1 summarizes the best available estimates for the pesticide uses of etridiazole. These estimates
are derived from a variety of published and proprietary sources available to the Agency. The data,
reported on an aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well as the
variability in using data from various information sources.
Table 1. Etridiazole Usage Summary
Crop
Lbs. Active
Ingredient Applied
(Wtd. Avg.)1
Percent Crop Treated
(Likely Maximum)
Percent Crop
Treated
(Wtd. Avg.)1
Agricultural Uses:
Citrus
Coffee
Cotton
Beans/Peas
Com
Peanuts
Safflower
(Other Crops)
Sorghum
Soybeans
0
no data
43,000
0
1,000
5,000
0
0
2,000
<1%
<1%
4.2%
<1%
<1%
2.0%
<1%
<1%
<1%
0.2%
0.0%
2.1%
0.0%
0.0%
0.3%
0.0%
0.0%
0.0%
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Crop
Wheat, Winter
Lbs. Active
Ingredient Applied
(Wtd. Avg.)1
0
Percent Crop Treated
(Likely Maximum)
<1%
Percent Crop
Treated
(Wtd. Avg.)1
0.0%
Turf:
Golf Course
Greens, Tees,
Fairways
5,000
4.3%
2.9%
Nursery and Greenhouse Ornamentals:
Container
Ornamentals
Greenhouse
22,000
6,000
1.2%
18.4%
0.9%
14.3%
Wtd Avg (Weighted average): the most recent years and more reliable data are weighted more heavily.
NOTES ON TABLE DATA
Usage data primarily covers 1987 - 1996.
Calculations of the above numbers may not appear to agree because they are displayed as rounded:
- to the nearest 1000 for Ib. ai (Therefore 0 = < 500)
- to the nearest whole percentage point for % of crop treated. (Therefore 0% = < 0.5%)
SOURCES: EPA data (1987-1996), USDA/NASS (1990-1996), California (1993-1995)
D. Regulatory History
Etridiazole (Terrazole®) was initially registered as a pesticide in 1962 by Uniroyal Chemical Company.
A Registration Standard for etridiazole was issued in September 1980 (NTIS #PB81-126716). The
Registration Standard summarized available data supporting the reregistration of products containing
etridiazole. The Registration Standard also required the submission of product chemistry, lexicological
and ecological effects data. Data Call-In notices were issued on June 24, 1992, February 18, 1993,
and October 13, 1995, and required the submission of product chemistry, toxicity, ecological effects
and fate, residue chemistry, and exposure data.
In an effort to promote transparency of the reregistration process and understanding of regulatory
decisions, the Agency, in cooperation with the U.S. Department of Agriculture (USDA), modified the
reregistration process. This modified process provides opportunities for stakeholders to ask questions
about and provide input to the risk assessment and risk mitigation strategies, via conference calls and
other formats. Consistent with this process, USDA held a conference call on May 11, 2000, with
interested stakeholders (i.e., growers, commodity groups, land grant universities, and others) to discuss
the basis of the calculated risks of etridiazole, and the Agency's resultant risk concerns. Information
obtained from users and growers during the call, such as etridiazole usage and occupational practices,
are reflected in this RED. The human health and environmental risk assessments for etridiazole were
-------
placed into the public docket with an invitation for public comment, as published in the Federal
Register on June 28, 2000.
A conference call was held on September 13, 2000 to summarize the results of the risk assessment and
risk management process for the registrants, USD A, growers and other interested stakeholders.
III. Summary of Etridiazole Risk Assessment
The following is a summary of EPA's human health and ecological risk findings and conclusions for the
thiazole pesticide etridiazole, as presented fully in the documents: Human Health Risk Assessment for
Etridiazole, June 6, 2000, Revised Toxicology Chapter of the Reregistration Eligibility Division,
September 13, 2000, Environmental Fate and Effects Division Risk Assessment for the
Reregistration Eligibility Decision on 5-ethoxy-3-trichloromethyl-l, 2,4-thiadiazole (Etridiazole),
May 22, 2000 and Terrazole: Refined Tier I Chronic Surface Water EECsfor Use in the Human
Health Drinking Water Risk Assessment, May 26, 2000.
The purpose of this decision document is to summarize the key features and findings of this risk
assessment in order to help the reader better understand the conclusions reached in the assessment.
While the risk assessments and related addenda are not included in this document, they are available on
the Agency's web page at www.epa.gov/pesticides, and in the OPP Public Docket.
A. Human Health Risk Assessment
1. Toxicity of Etridiazole
The toxicity database for etridiazole is incomplete, and contains no acceptable subchronic studies for
use in risk assessment. Data gaps for etridiazole also include a multigeneration reproduction study in
rats, a chronic toxicity study in dogs, and a cancer study in mice that meet chronic toxicity test
guidelines. These studies have been previously submitted but do not meet current guideline
requirements for a food-use chemical. In addition, there is insufficient data to assess the neurotoxic
potential of etridiazole. However, additional studies (i.e. delayed neurotoxicity study in the hen, acute
neurotoxicity study, subchronic neurotoxicity study and/or developmental neurotoxicity study) are not
required at the present time because there is no evidence of neurotoxicity in the available guideline
toxicity studies. These studies are placed in reserve status pending submission and evaluation of a
repeat multigeneration reproduction study in rats and a chronic toxicity study in dogs.
No quantitative or qualitative evidence of increased susceptibility in rats or rabbits was observed
following pre- and/or postnatal exposure to etridiazole. There is no evidence of neurotoxicity in the
available guideline toxicity studies.
-------
Available chronic toxicity data indicate that the primary target for toxicity is the liver following chronic
exposure to etridiazole in rats. At 640 ppm (30.43 mg/kg/day in males, 38.45 mg/kg/day in females),
systemic toxicities observed in the 2-year rat carcinogenicity study included decreased body weight
gain in females, increased absolute and relative liver weight in males, hepatocytomegaly in males,
spongiosis hepatis in males, clear, basophilic, and eosinophilic hepatocellular alterations in both sexes,
hepatic centrilobular pigmentation in females, cholangiectasis in females, renal tubule cell karyomegaly in
males and females and testicular interstitial cell hyperplasia in males. In a two-year, non-guideline
chronic toxicity study with dogs, systemic toxicities in both sexes manifested as increased serum
aspartate transferase (SGOT) and serum alkaline phosphatase (ALK;SAP) activity, increased relative
liver weights, liver pathology consistent with cholestatic hepatis with secondary bile nephrosis and
increased prothrombin time at a dose level of 25 mg/kg/day.
Etridiazole was classified by the Agency's Health Effects Division Cancer Peer Review Committee
(CPRC) as a Probable Human Carcinogen. This classification is based on the following factors: (i)
occurrence of multiple tumor types in male and female rats (tumor sites noted were the liver, bile duct,
mammary gland, thyroid, and testes) including the induction of a rare bile duct tumor
(cholangiocarcinoma), and (ii) non-neoplastic lesions observed in similar target organs that lend
support to the association of etridiazole exposure with the induction of tumors; increased absolute and
relative liver weight (males), hepatocytomegaly (males); clear, basophilic, and eosinophilic cellular
alterations (males and females); cholangiectasis (females); centrilobular pigmentation (females);
spongiosis hepatis of the liver (males); and testicular interstitial cell hyperplasia (males) and (iii) positive
mutagenicity data. The carcinogenicity study in mice was determined to be unacceptable and not
adequate for assessment of the carcinogenic potential of etridiazole in this species. A new study is
required. The CPRC calculated a unit risk or Qj*, of 3.33 x 10"2 (mg/kg/day)"1' based on the
occurrence of thyroid follicular cell combined adenomas/carcinomas in male rats.
Etridiazole induced genotoxic responses in several mutagenicity assays and is considered a mutagen.
Positive responses occurred in a gene mutation assay in Salmonella typhimurium, in the in vitro
cytogenetics assay in Chinese hamster ovary cells, and in the two in vitro sister chromatid exchange
assays in Chinese hamster ovary cells.
2. Dietary Toxicity
A brief overview of the toxicity studies used for endpoints in the dietary risk assessment is outlined in
Table 2. Further details on the toxicity of etridiazole can be found in the June 6, 2000 Human Health
Risk Assessment and the Revised Toxicology Chapter of the Reregistration Eligibility Decision,
September 13, 2000.
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Table 2. Summary of Etridiazole Dietary Toxicity Endpoints
Exposure
Scenario
Acute Dietary
(Females
13-50)
Acute Dietary
(General
Population)
Chronic
Dietary
Chronic
(Cancer)
Dietary
Dose
(mg/kg/day)
NOAEL=15
UF=100
FQPA SF=1
Endpoint/Rationale
Reduced fetal body weights, decreased viability, and
external and skeletal malformations/variations at the
LOAEL of 45 mg/kg/day. The skeletal malformations/
variations (missing stemebrae and tail defects) are
presumed to occur after a single exposure (dose) and
thus are appropriate for acute risk assessment. Since
the selected NOAEL is based on a developmental
endpoint, it is applicable only to the population
subgroup, females 13-50 years old.
Study
Developmental
Toxicity - Rabbit
MRID 0010499
Acute RfD = 0. 15 mg/kg Acute PAD = 0. 15 mg/kg
An appropriate endpoint attributable to a single exposure (dose) was
not identified in oral toxicity studies (including the developmental
toxicity studies in rats and rabbits) that is applicable to
subpopulations other than females of childbearing age (13-50 years
old).
NOAEL=4.8
UF=300
FQPA SF=3
Increased absolute and relative liver weights, renal
tubule cell karyomegaly, hepatocytomegaly and
spongiosis hepatis at the LOAEL of 30.43 mg/kg/day.
The uncertainty factor includes lOx for interspecies
extrapolation, lOx for intraspecies variation, and 3x
applied under FIFRA for toxicology data gaps.
Carcinogenicity -
Rats
MRID 40747901
Chronic RfD = 0.016 mg/kg/day Chronic PAD = 0.005 mg/kg/day
Group B2 chemical - Probable human carcinogen - Qj* = 3.33 x 10"2
(mg/kg/day)"1 in human equivalents [converted from animals to
humans by use of the (mg/kg body weight) cross species scaling
factor] .
Carcinogenicity -
Rats
MRID 40747901
a. Acute Dietary Endpoint
For females 13-50 years of age, the NOAEL of 15 mg/kg/day was established based on reduced fetal
body weight, decreased viability and external and skeletal malformations/ variations in the rabbit
developmental toxicity study observed at the LOAEL of 45 mg/kg/day. Because these effects
occurred in utero, they are applicable only to females 13-50 years of age. Based on available acute
toxicity studies, no other endpoints identified were attributable to a single dose. Thus, the only acute
dietary hazard is for females 13-50 years of age, and so acute dietary risk was assessed only for this
population subgroup.
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b. Chronic (Non-Cancer) Dietary Endpoint
The NOAEL of 4.8 mg/kg/day was established based on increased absolute and relative liver weights,
renal tubule cell karyomegaly, hepatocytomegaly and spongiosis hepatis observed in a carcinogenicity
study in rats at the LOAEL of 30.43 mg/kg/day. The Agency determined that the two-year chronic
toxicity study in dogs previously used to establish the chronic RfD does not meet the current guideline
requirements. Due to the numerous deficiencies observed as a result of the age of this chronic toxicity
study (1966-1969), it is not adequate for establishing the RfD. Consequently, the two-year rat
carcinogenicity study was selected for this exposure scenario. A FIFRA uncertainty factor of 3x was
used in the chronic dietary risk assessment due to this data gap.
c. Chronic (Cancer) Dietary Endpoint
A linear low-dose approach (Qi*) was used to characterize human health risk. The unit risk, or Qx*,
based on the occurrence of thyroid follicular cell combined adenomas/carcinomas in male rats, is 3.33 x
10"2 (mg/kg/day)"1 in human equivalents. Results of a carcinogenicity study in mice were equivocal due
to deficiencies in the study design. The Agency is requiring a new carcinogenicity study in mice. In
spite of the poor quality of the mouse study, the presence of gross and histopathological lesions in the
lungs indicates a concern for possible carcinogenicity in a different organ in a different species.
3. FQPA Safety Factor
Etridiazole lacks an acceptable multigeneration reproduction study which could identify potential
reproductive effects following pre-/postnatal exposure to etridiazole. However, the FQPA Safety
Factor Committee concluded that the lOx safety factor could be reduced to 3x for the following
reasons:
1) there is no quantitative or qualitative indication of increased susceptibility in the prenatal
developmental toxicity studies in rats and rabbits;
2) although the multi-generation reproduction study in rats was determined to be an
unacceptable guideline study and not adequate for regulatory purposes by the Hazard
Identification Assessment Review Committee, it is noted that the observed offspring
effects in this study occurred only at a treatment level which resulted in parental toxicity;
and
3) adequate data are available or conservative modeling assumptions are used to assess
the potential for dietary (food and drinking water) exposure to infants and children.
-------
The FQPA safety factor is applicable to chronic dietary risk assessment for all population subgroups
since there is uncertainty due to the data gap for the two-generation reproduction study in rats which
could identify potential reproductive effects. The FQPA safety factor does not apply to acute dietary
risk assessment since no increased susceptibility was demonstrated following in utero exposure, and
because the multi-generation reproduction study in rats is not expected to provide information on the
potential for adverse effects occurring after a single exposure (dose).
4. Hazard Determination
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which reflects the
reference dose (RfD), either acute or chronic, that has been adjusted to account for the FQPA safety
factor (SF). The RfD is an estimated level of daily exposure to a pesticide residue which, over a
70-year human life span, is believed to have no significant deleterious effects. Where the FQPA SF has
been removed (equivalent to Ix), the acute or chronic RfD is equivalent to the acute or chronic PAD.
In the case of etridiazole, the FQPA SF has been removed (equivalent to a factor of Ix) for the acute
dietary assessment. For the chronic dietary risk assessment, the RfD includes a 3x uncertainty factor
applied under FIFRA due to the lack of a chronic oral toxicity guideline study in dogs, and the cPAD
includes the 3x FQPA safety factor.
a. Acute PAD
An acute RfD of 0.15 mg/kg/day was derived for females 13-50 years old based on the NOAEL of 15
mg/kg/day in the developmental toxicity study in rabbits and an uncertainty factor (UF) of 100 (lOx for
interspecies extrapolation and lOx for intraspecies variation). The FQPA SF was removed (equivalent
to a factor of Ix) for this population. Consequently, the acute PAD (aPAD) is numerically equivalent to
the acute RfD at 0.15 mg/kg/day for this population subgroup.
b. Chronic (Non-Cancer) PAD
A chronic (non-cancer) RfD of 0.016 mg/kg/day was derived based on aNOAEL of 4.8 mg/kg/day in
the carcinogenicity study in rats with an uncertainty factor of 300 (lOx for interspecies extrapolation,
lOx for intraspecies variation, and 3x applied under FIFRA for lack of a chronic toxicity guideline study
in dogs). The FQPA safety factor of 3x applies to the chronic dietary assessment. Consequently, the
chronic PAD (cPAD) is 0.005 mg/kg/day.
10
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c. Chronic (Cancer) Unit Risk
A linear low-dose approach (Qi*) was used to characterize human health risk. The unit risk, or Qj*,
based on the occurrence of thyroid follicular cell combined adenomas/carcinomas in male rats, is 3.33 x
10"2 (mg/kg/day)"1 in human equivalents.
5. Exposure Assumptions
The dietary (food) exposure analysis used for etridiazole is based on the Dietary Exposure Evaluation
Model (DEEM™). The DEEM™ analysis used the individual food consumption as reported by
respondents in the USDA 1989-91 Continuing Surveys for Food Intake by Individuals (CSFII). No
Pesticide Data Program (PDF) or Food and Drug Administration (FDA) monitoring data were
available and crop field trial data were not required for crops on which etridiazole is used as a seed
treatment. Field trial data were available only for cottonseed at a 6x application rate (in-furrow at-
planting treatment). Residues of etridiazole detected were less than the limit of quantitation (LOQ),
which is where the tolerance is set. Based on available metabolism data, there is no reasonable
expectation of finite regulable residues [etridiazole parent compound and the monoacid metabolite (3-
Carb-T)] in meat, poultry, poultry and meat by-products, fat, milk and eggs. Therefore, animal
commodities are not included in the dietary risk assessment. The risk assessment may be modified
upon establishment of a tolerance to support use on imported tomatoes. This assessment currently uses
conservative assumptions for imported tomatoes; therefore, dietary risk estimates are not likely to
increase.
6. Dietary (Food) Risk Assessment
a. Acute Dietary Risk
Acute dietary risk was calculated considering what is eaten in one day and tolerance level residue
values in food. A risk estimate that is less than 100% of the acute Population Adjusted Dose (aPAD)
(the dose at which an individual could be exposed on any given day and no adverse health effects
would be expected) does not exceed the Agency's level of concern.
Tolerance level residues and 100% crop treated were assumed for all commodities. Etridiazole is not
registered for use on domestically grown tomatoes, but it is used on imported tomatoes. A
conservative value of 100% crop treated was used for all tomato commodities (assumes all tomatoes
consumed are treated with etridiazole). The established tolerance for domestic tomatoes (0.15 ppm)
was used for the residue level for tomato commodities.
11
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A Tier 1 deterministic approach was used to estimate acute dietary risk. When using a deterministic
approach, the percentile of concern is the 95th, although results for the 99th and 99.9th percentiles were
also calculated. The results of the analysis are shown in Table 3. At the 95th percentile of exposure,
risk estimates for females 13-50 years old, the only subgroup of concern, are 1% of the aPAD and thus
are not of concern. For more information on acute dietary risk assessment, see the Dietary Exposure
and Risk Analysis section of the June 6, 2000 Human Health Risk Assessment.
Table 3. Acute Dietary Risk (Food Only)
Subgroups
Females (13-50 years)
95th Percentile
Exposure
(mg/kg)
0.001541
%
aPAD
1.0
99th Percentile
Exposure
(mg/kg)
0.002795
%
aPAD
1.9
99.9th Percentile
Exposure
(mg/kg)
0.005323
%
aPAD
3.6
b. Chronic (Non-Cancer) Dietary Risk
A Tier 1 assessment was used to estimate chronic (non-cancer) dietary risk. Chronic (non-cancer)
dietary risk is calculated by using the average consumption values for food and average residue values
for those foods over a 70-year lifetime. A risk estimate that is less than 100% of the chronic PAD (the
dose at which an individual could be exposed over the course of a lifetime and no adverse health effects
would be expected) does not exceed the Agency's level of concern.
As with the acute dietary assessment, tolerance level residues and 100% crop treated were assumed
for all commodities. A conservative value of 100% crop treated was used for all tomato commodities
(assumes all tomatoes consumed are treated with etridiazole). The established tolerance for domestic
tomatoes (0.15 ppm) was used for the residue level for tomato commodities.
The risk estimate for the mostly highly exposed subgroup, children 1-6, is 31% of the cPAD and thus is
not of concern. The results of the analysis, based on the uses supported through reregistration, are
summarized in Table 4.
Table 4. Chronic Non-Cancer Risk (Food Only)
Subgroup
U.S. Population
Non-nursing infants
Children (1-6 years)
Exposure
(mg/kg/day)
0.000688
0.001024
0.001534
%cPAD
14%
20%
31%
12
-------
Subgroup
Females 13-19 years (not
pregnant/not nursing)
Females 13-50 years
Males 13- 19 years
Exposure
(mg/kg/day)
0.000676
0.000538
0.000767
%cPAD
14%
11%
15%
For more information on chronic dietary risk assessment, see the Dietary Exposure and Risk Analysis
section of the June 6, 2000 Human Health Risk Assessment.
c. Chronic (Cancer) Dietary Risk
A Tier 3 assessment was used to calculate chronic (cancer) dietary risk. Exposure assumptions
included residue levels of one-half the combined limits of quantitation for etridiazole and its monoacid
metabolite (3-Carb-T) for all commodities except tomatoes, tolerance level residues for tomatoes (0.15
ppm), weighted average percent crop treated for all commodities except tomatoes, and 1% crop
treated for imported tomatoes.. The chronic exposure value is combined with the Qx* to determine the
lifetime (cancer) risk estimate. The results of the dietary cancer risk assessment are shown in Table 5.
Table 5. Cancer Dietary Risk (Food Only)
Subgroup
U.S. Population
Exposure
(mg/kg/day)
0.000005
Lifetime Risk
Estimate1
1.6xlO'7
'Lifetime Risk Estimate = 70-year Lifetime Exposure (mg/kg/day) x Qj *
= (0.000005 mg/kg/day) x 3.33 x 10'2 (mg/kg/dayj1
The Agency generally considers IxlO"6 (1 in 1 million) or less to be negligible risk for cancer dietary
exposure. The results of this analysis indicate that the cancer dietary (food) risk associated with the
uses supported through reregistration is 1.6 x 10"7, and thus is not of concern. For more information on
chronic (cancer) dietary risk assessment, see the Dietary Exposure and Risk Analysis section of the
June 6, 2000 Human Health Risk Assessment.
7. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through ground and surface water contamination.
EPA considers acute (one day) and chronic (lifetime) drinking water risks and uses either modeling or
13
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actual monitoring data, if available, to estimate those risks. To determine the maximum contribution
from water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed
by food and then determines a "drinking water level of comparison" (DWLOC) to ascertain whether or
not modeled or monitored concentrations exceed this level. Estimated environmental concentrations
(EECs) that are above the corresponding DWLOC exceed the Agency's level of concern. Modeling is
generally considered to be an unrefined assessment and provides high-end estimates.
Monitoring data are not available for etridiazole to enable a quantitative exposure analysis and risk
assessment, so estimates were developed using models. These models estimate levels of etridiazole
only, and not its degradates. The results of the acute and chronic drinking water assessments, EECs
and DWLOCs are summarized in Table 6. Shaded areas denote estimated concentrations that exceed
the DWLOCs.
a. Surface Water
Two scenarios were used to estimate environmental concentrations for surface water. The turf scenario
reflects the golf course use and is the worst case scenario. Therefore, an estimate of the chronic
surface water EECs was also done for the cotton in-furrow use since the application rate is lower and a
more refined model is available. All EEC values reflect only etridiazole per se and do not include the
degradate of dietary significance, 3-Carb-T. Available environmental fate data indicate that
approximately 7% of etridiazole may degrade to form 3-Carb-T. Given the low volume of etridiazole
used on golf course turf and the relative stability of the parent compound to abiotic degradation, the
metabolite is not expected to contribute significantly to drinking water risk.
For surface water, GENEEC was used to estimate peak (acute) and 56-day concentrations resulting
from the use on golf course tees, greens and fairways. In the past, EPA used a Tier 2 PRZM-EXAMS
screening model to estimate the upper-bound concentrations in surface water for turf as well as
agricultural uses. This model, in general, is based on more refined, less conservative assumptions than
the Tier 1 GENEEC screening model, and provides estimates for 36-year mean concentrations.
However, the Agency has determined that the Tier 2 PRZM-EXAMS model does not have the
appropriate parameters to accurately model turf runoff; therefore, only GENEEC was used to model
turf use for this assessment. Chronic EECs derived from GENEEC for turf use were, however, refined
with the incorporation of a percent crop area (PC A) factor. It was assumed that 87% of the watershed
is in golf course use, and that 19.5% of the golf course is actually treated (assuming tees, greens and
fairways average about 35 acres out of a 180-acre golf course, or 19.5%). The resulting PC A factor is
17%.
Peak EECs in surface water (230 ppb) based on two applications at 3.8 Ibs ai/A at 10-day intervals to
golf course turf result in acute risks that are below the drinking water levels of comparison (DWLOCs)
14
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of 4300 ppb for females 13-50 years of age, the population subgroup of concern. Thus, acute risks
from surface water are not of concern.
Potential 56-day average concentrations of etridiazole in surface water after application to turf (32.3
ppb) result in chronic non-cancer risk that is not of concern for any population subgroup. For cotton
use, potential chronic (36-year average) concentrations of etridiazole in surface water are 0.05 ppb,
which is below the non-cancer and cancer DWLOCs for all population subgroups, and thus are not of
concern.
Potential concentrations of etridiazole in surface water for turf use (32.3 ppb), assuming treatment of
tees, greens and fairways, are above the cancer DWLOC of 1 ppb for the general U.S. population.
Thus, chronic cancer risk from surface water after application to golf course turf is of concern.
b. Ground Water
Ground water concentrations of etridiazole were estimated using the SCI-GROW (Tier I) computer
model. Model simulations indicate that the maximum total etridiazole residue concentration after two
applications at 3.8 Ibs ai/A at 10-day intervals is not likely to exceed 0.93 ppb. This is below the
DWLOCs for all population subgroups for acute, chronic and cancer risks, and thus is not of concern.
The results of both surface and ground water model estimates and their comparison with the DWLOCs
are summarized in Table 6. For more information on drinking water risks and the calculations of the
DWLOCs, see the Water Exposure section of the June 6, 2000 Human Health Risk Assessment, the
Water Resource section of the Environmental Fate and Effects Division Risk Assessment for the
Reregistration Eligibility Decision on 5-ethoxy-3-trichloromethyl-l, 2,4-thiadiazole (Etridiazole),
May 22, 2000 and Terrazole: Refined Tier I Chronic Surface Water EECsfor Use in the Human
Health Drinking Water Risk Assessment, May 26, 2000.
15
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Table 6. Drinking Water DWLOC and EEC Comparisons
Population Subgroup
Females (13-50 years)
STon-nursing infants (<1
year)
Children (1-6 years)
Females (13-19 years) not
sregnant, not nursing
Males (13-19 years)
U.S. population
DWLOCs (ppb)
Acute
4300
NC5
NC
NC
NC
NC
Chronic
Non-
Cancer
130
40
35
130
150
150
Cancer
1
EECs (ppb)
Ground
Water1
Acute &
Chronic
0.93
Surface Water
Acute2
230
Chronic
Cancer & Non-Cancer
Tier I3
(Turf)
32.3
Tier 24
(Cotton)
0.05
'Based on SCIGROW model, Tier 1, using typical application rate (two applications at 3.8 Ib ai/A at 10-day intervals)
to golf course tees, greens and fairways.
2Based on GENEEC model, Tier 1, using typical application rate (two applications at 3.8 Ib ai/A at 10-day intervals) to
golf course tees, greens and fairways, peak concentration.
3Based on GENEEC model, Tier 1, using typical application rate (two applications at 3.8 Ib ai/A at 10-day intervals to
golf course fairways and five applications at the same rate to tees and greens), 56-day average concentration.
4Based on PRZM/EXAMS model, Tier 2, using typical application rate for in-furrow application of 0.38 Ib ai/A, 36-
year mean, on cotton.
5Not calculated. Acute DWLOC was calculated only for females 13-50 because this was the only group for which
acute dietary exposure was assessed.
8. Residential and Other Non-Occupational Risk
There are no registered homeowner uses of etridiazole, so a residential risk assessment was not
conducted. The only non-occupational exposure expected to occur is short-term exposure on treated
golf courses.
a. Short-Term Non-Occupational Non-Cancer Risk
The short-term lexicological endpoint for etridiazole is in utero effects observed in a developmental
study in rabbits at the LOAEL of 45 mg/kg/day. This is the same study and endpoint used in the acute
dietary assessment and is applicable only to females of childbearing age. A risk assessment was
16
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conducted for female golfers using the developmental NOAEL of 15 mg/kg/day. The FQPA SF is not
applicable to this endpoint for the reasons discussed in Section HI. A. 1 .b. For this assessment, the
default dermal absorption factor of 100% was used. Because an appropriate short-term endpoint was
not available for the general population, including infants and children, a risk assessment for this
exposure scenario was not conducted for the general population. Inhalation exposures are not
expected for golfers, and so were not calculated for golf course scenarios.
An acceptable chemical-specific study of transferrable turf residues was used to estimate the risk
presented by postapplication entry onto a golf course. A golfer was assumed to be exposed for four
hours per day, 18 days over the course of one year, 12 hours after application of etridiazole. For the
population subgroup assessed, females 13-50 years of age, a margin of exposure (MOE) of 100 or
greater is not of concern. The MOE was estimated at 17,000, which is not of concern.
b. Non-Occupational Cancer Risk
Cancer risk estimates were determined for all adult golfers using the same 100% dermal absorption
factor, residue data and exposure parameters as for the non-occupational non-cancer risk assessment.
The estimated cancer risk for adult golfers is 8.9 x 10"7, which is a level the Agency considers to be
negligible for excess lifetime cancer risk.
9. Aggregate Risk
Aggregate risk includes the combined risk from dietary exposure through both food and drinking water,
as well as from exposures to residential and other non-occupational sources (in this case, exposure to
treated golf courses).
a. Acute Aggregate Risk
The acute aggregate risk assessment considers a one-day oral exposure from food and water only.
Females 13-50 years old were the only population subgroup for which acute assessments were done.
Estimated risks for etridiazole from food and water indicate that 1% of the aPAD at the 95th percentile
is occupied by dietary (food) exposure, and that surface and ground water EECs (230 ppb and 0.93
ppb, respectively) are below the DWLOC for this population subgroup (4300 ppb). Thus, acute
aggregate risk from food and water is not of concern.
17
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b. Short-Term Aggregate Risk
In order to determine the short-term aggregate risk, the Agency combines the short-term risks from any
non-occupational exposures with the risks from food and drinking water. In the case of etridiazole, the
only non-occupational exposures are by golfers on treated golf courses. The only short-term toxicity
endpoint identified for etridiazole was for females 13 to 50 years of age; consequently, the short-term
aggregate risk is calculated only for this subpopulations. Since the Agency does not have any reliable
monitoring data from which to estimate the exposures in water, it had to rely on the DWLOC method
to determine if the risk cup is exceeded. The short-term risk for golfers (expressed as a margin of
exposure) was estimated to be 17,000. The short-term dietary risk for food for the subpopulations of
concern was estimated to be 0.4%, equivalent to an MOE of 28,000. (The Agency assumes that the
chronic exposure from etridiazole residues in food is equal to the short-term exposure.) By adding the
exposures associated with these risks, comparing them to the short-term toxicological endpoint (i.e., a
NOAEL of 15 mg/kg/day), and determining the amount of room left in the risk cup, one can determine
the level of residues in drinking water that would be allowed, assuming that a person consumes 2 liters
of water per day (the DWLOC), before the cup is full. In this instance, it was determined that drinking
water could contain up to 4300 ppb before there is a risk of concern (i.e., a margin of exposure of less
than 100). The Agency did not model for short-term exposures from drinking water but instead used
the model estimate for surface water acute exposures for comparison to the DWLOC. This is a
conservative estimate since the level of residues in drinking water to which a person could be exposed
over a short-term period would be expected to be less than the maximum (or acute) level to which one
could be exposed. The short-term DWLOC was estimated to be 4300 ppb, while the estimated acute
exposure was modeled to be 230 ppb.
c. Chronic (Non-Cancer) Aggregate
Chronic non-cancer aggregate risk includes exposure from food, water and non-occupational sources,
which in this case includes only exposure to treated golf courses. There are no chronic non-
occupational exposures, so chronic non-cancer aggregate risk estimates include only chronic dietary
(food and water) exposures. Estimated risks from food for the most highly exposed subgroup, children
1-6, indicate that 31% of the cPAD is occupied by dietary (food) exposure, and that chronic surface
and ground water EECs (32.3 ppb and 0.93 ppb, respectively) are below the DWLOC for this
population subgroup (35 ppb). Therefore, chronic non-cancer aggregate risks are not of concern.
d. Chronic (Cancer) Aggregate
Cancer aggregate risk estimates include chronic dietary (food and water) and non-occupational (in this
case, golf course) exposures. The estimated cancer risk for adult golfers is 8.9 x 10"7, and the
estimated cancer risk from food only is 1.6 x 10"7. The combined cancer risk estimate for food and golf
18
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course exposures is l.lxlO"6' which is not of concern. However, the Tier 1 chronic surface water EEC
reflecting use on turf (32.3 ppb) exceeds the cancer DWLOC for the general U.S. population (1 ppb).
Therefore, cancer aggregate risk estimates for the general population are of concern due to chronic
surface water EECs associated with turf use.
10. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a pesticide, or re-
entering treated sites. Occupational handlers of etridiazole include individual (or private) users and
professional (or commercial) applicators who mix, load, and/or apply pesticides. Dermal and inhalation
risk for all of these potentially exposed populations is measured by a Margin of Exposure (MOE),
which determines how close the occupational exposure comes to a No Observed Adverse Effect Level
(NOAEL) from an animal study. For etridiazole, short- and intermediate-term MOEs greater than 100
and long-term MOEs greater than 300 are not of concern. The Agency also conducted an assessment
of the cancer risk associated with etridiazole following exposures to occupational handlers. Cancer
risks to workers of IxlO"6 (1 in 1 million) and less are considered to be negligible. For more
information on the assumptions and calculations of potential risks to workers, see the Revised
Occupational and Residential Exposure Assessment for the Reregistration Eligibility Decision
Document, June 5, 2000 and the Occupational Exposure section of the June 6, 2000 Human Health
Risk Assessment.
a. Occupational Toxicity
The acute toxicity profile for etridiazole is summarized below in Table 7.
19
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Table 7. Acute Toxicity Profile for Etridiazole1
Guideline
870.1100
(§81-1)
870.1200
(§81-2)
870.1300
(§81-3)
870.2400
(§81-4)
870.2500
(§81-5)
870.2600
(§81-6)
MRID
43724501
43724502
43724503
43724504
43724505
43724506
Study
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation -
Rabbit
Primary Dermal Irritation -
Rabbit
Dermal Sensitization -
Guinea Pig-
unspecified purity of
Terrazole technical
Results
LD50 (males) =1141 mg/kg
LD50 (females) = 945 mg/kg
LD50 (males and females
combined) = 1028 mg/kg
LD50 (males and females
combined) > 5000 mg/kg
LC50 (males and females
combined) > 5.7 mg/L
Moderate Eye Irritant
Non Irritant
Moderate Dermal Sensitizer
Toxicity
Category
III
IV
IV
III
IV
N/A
'The percent active ingredient of the technical test material used in each of the acute toxicity studies was reported as
98.6% a.i., unless specified otherwise.
The Agency anticipates that, with one exception, only short- and intermediate-term occupational
exposures to etridiazole will occur, given its seasonal use pattern. The exception is postapplication
handling of treated potting soil by nursery and greenhouse workers, where exposure could occur on a
long-term basis.
No acceptable dermal penetration study is available in the etridiazole toxicity database. In addition, the
dermal toxicity studies submitted to the Agency were determined to be inadequate for regulatory
purposes. Therefore, the default value of 100% dermal absorption was used in this risk assessment.
However, the acidic pH of etridiazole technical (pH 3-4 in water) would cause considerable skin
irritation and would most likely breach the skin barrier. Therefore, 100% dermal absorption is
possible. Oral studies were used for all of the inhalation endpoints. Therefore, the default value of
100% inhalation absorption was used.
1) Short-Term Dermal and Inhalation Endpoints
The short-term endpoint for calculating dermal and inhalation risk was reduced fetal body weights,
decreased viability and increased skeletal malformations/variations observed in an oral developmental
toxicity study in rabbits at a LOAEL of 45 mg/kg/day. A NOAEL of 15 mg/kg/day was selected.
20
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2) Intermediate- and Long-Term Dermal and Inhalation
Endpoints
The intermediate- and long-term endpoint (dermal and inhalation) was increased absolute and relative
liver weights, renal tubule cell karyomegaly, hepatocytomegaly and spongiosis hepatis in male rats
observed at the LOAEL of 30.4 mg/kg/day in a carcinogenicity study. The NOAEL was 4.8
mg/kg/day. A 3x FIFRA uncertainty factor was applied to the long-term endpoints due to the lack of
an acceptable guideline chronic toxicity study.
3) Cancer Endpoint
Etridiazole is classified as a Group B2 Probable Human Carcinogen based on multiple tumor types in
male and female rats. A linear low-dose (Qi*) approach was used to characterize human health risk.
The unit risk, Qj*, is 3.33 x 10"2 (mg/kg/day)"1 in human equivalents.
An overview of the toxicity endpoints used for the occupational risk assessment is outlined in Table 8.
For more occupational toxicity information used to assess risks to workers, see the Hazard Profile
section of the June 6, 2000 Human Health Risk Assessment and the Revised Toxicology Chapter of
the Reregistration Eligibility Decision, September 13, 2000.
Table 8. Summary of Etridiazole Occupational Toxicity Endpoints
Exposure
Scenario
Short-Term
(Dermal and
Inhalation)
Target MOE 100
Intermediate-Term
(Dermal and
Inhalation)
Target MOE 100
Long-Term
(Dermal and
Inhalation)
Target MOE 300**
Dose
(mg/kg/day)
Oral
NOAEL=15
Oral
NOAEL=4.8
Absorption
Factor*
100%
100%
Endpoint
Reduced fetal body weights,
decreased viability and increased
skeletal malformations/variations at
the LOAEL of 45 mg/kg/day
Decreased body weight, increased
liver weight (absolute and relative),
renal tubule cell karyomegaly,
hepatocytomegaly, spongiosis
hepatis, cholangiectasis,
centrilobular pigmentation; liver,
testicular and thyroid tumors at the
LOAEL of 30.4 mg/kg/day
Study
Developmental-
Rabbit
(00104999)
Oncogenicity -
Rat (40747901)
21
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Exposure
Scenario
Dose
(mg/kg/day)
Absorption
Factor*
Endpoint
Study
Chronic
(Cancer)
Group B2 - "Probable human carcinogen" - Qi* = 3.33 x 10 2 (mg/kg/day)"1 in human
equivalents [converted from animals to humans by use of the (mg/kg body weight f cross
species scaling factor].
*Oral NOAELs were selected. Dermal and inhalation absorption factors of 100% (default values) were used for
route-to-route extrapolation.
**MOE includes the conventional lOOx uncertainty factor (lOx for interspecies variability, lOx for interspecies
extrapolation) and 3x for lack of a chronic oral toxicity study in dogs.
b. Occupational Exposure
Chemical-specific handler exposure data were not available for etridiazole, so risks to pesticide
handlers were assessed using data from the Pesticide Handlers Exposure Database (PHED) Version
1.1, and standard assumptions about average body weight, work day, daily areas treated, volume of
pesticide used, etc. The exposure factors (e.g., body weight, amount treated per day, protection
factors, etc.) are all standard values used by the Agency, and the PHED unit exposure values are the
best available estimates of exposure.
Anticipated use patterns, application methods, and range of application rates were derived from current
labeling. The daily amount treated is based in part on standard assumptions and in part on information
provided by the technical registrant. Etridiazole can be applied by groundboom, chemigation,
handwand, broadcast spreader, tractor-drawn spreader or hand dispersal.
In-furrow crop treatment rates (soil-incorporated) for etridiazole range from 0.13 to 0.38 Ibs. ai per
acre. Soil is also treated for ornamental plants for nurseries and greenhouses. The typical rate for soil
drench treatment is 6 oz ai/1000 sq. ft. (0.375 lb/1000 sq. ft. or 16.3 Ib/acre), with a range of 1.5 oz
ai/1000 sq. ft. (4.1 Ib) to 17.5 oz ai/1000 sq. ft. (1.09 Ib ai/1000 sq. ft. or 47.6 Ib ai/acre). Etridiazole
can also be added dry to potting soil, typically at 1.1 oz ai/cubic yard. Application to turf on golf
courses is in the range of 0.7 to 2.8 oz ai/1000 sq. ft. (1.9 Ib ai/acre to 7.6 Ib ai/acre). Seed treatment
rates range from 0.0078 Ib ai/100 Ibs seed to 0.0625 Ib ai/100 Ib seed.
Occupational handler exposure assessments are conducted using different levels of personal protection.
The Agency typically evaluates all exposures with minimal protection and then adds additional
protective measures using a tiered approach (going from minimal to maximum levels of protection) to
obtain an appropriate MOE. The lowest tier is represented by the baseline exposure scenario (i.e.,
single layer clothing, socks, and shoes), followed by, if MOEs are still of concern, increasing levels of
22
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risk mitigation [i.e., personal protective equipment (PPE) and engineering controls (EC)]. End use
product labels currently specify a wide range of personal protective equipment.
Based on the handler activity pattern, the duration of exposure is expected to be only short-term (1-7
days) and intermediate-term (1 week to 6 months) for occupational handlers. The use pattern for turf
products results in the greatest amount of exposure with a maximum of up to 10 applications per season
for golf courses. Therefore, long-term (chronic) exposure is not anticipated nor expected, and a long-
term (chronic) exposure risk assessment for handlers is not required.
c. Handler Risks
There are potential occupational exposures to pesticide handlers using etridiazole. Occupational
handlers are potentially exposed via dermal and inhalation routes. Worker risk is measured by a
Margin of Exposure (MOE) which determines how close occupational exposure comes to the NOAEL
taken from animal studies. Short- and intermediate-term MOEs that are greater than 100 are not of
concern. Based on the current use patterns, 24 occupational exposure scenarios were identified for
etridiazole which are presented as a total of 55 assessments to account for variable application rates.
EPA conducted an assessment of the cancer risk associated with etridiazole following exposures to
occupational handlers. For the cancer assessment, two scenarios were used. "Private" represents
typical exposures (e.g., typical application rates) experienced by growers who apply etridiazole to their
own fields, greenhouse, golf course, etc., while "commercial" represents typical exposures experienced
by commercial handlers. Because greenhouses, nurseries, and golf courses usually have their own
certified pesticide applicators, and because private and commercial farm sizes vary widely, multipliers
ranging from 3x to lOx were applied to the number of expected exposures by private handlers in order
to obtain the number of exposures expected for commercial handlers.
Risks for occupational handlers of etridiazole are of concern for some scenarios. In some cases, the
calculated risks can be mitigated with additional protective measures such as engineering controls.
However, for some scenarios, engineering controls are not feasible. The Agency has risk concerns for
occupational handlers loading/applying liquids and dusts for commercial seed treatment,
loading/applying granules by belly grinder, power dust blower and push-type spreader,
mixing/loading/applying wettable powders, and dispersing granules by hand. These scenarios and
corresponding risk estimates are shown in Table 9. Footnotes accompanying the risk estimates denote
the level of PPE needed to achieve the MOE or cancer risk estimate shown. In many cases, this level
of PPE exceeds that specified on current product labels. Current product labels vary widely in the
levels of PPE specified, from long-sleeved shirt and pants, shoes and socks to double-layer clothing,
chemical-resistant gloves, footwear, eyewear and respiratory protection.
23
-------
The levels of protection that formed the basis for calculations of exposure in this assessment are as
follows:
Baseline: Long-sleeved shirt and long pants, shoes and socks
Minimum PPE: Baseline and chemical resistant gloves
Maximum PPE: Baseline, chemical resistant gloves, coveralls and an organic vapor respirator
Engineering controls: Engineering controls such as a package-based system (e.g., water-soluble
packaging for wettable powders) or other closed systems. Some engineering
controls are not applicable for certain scenarios (e.g., for handheld application
methods there are no known devices that can be used to routinely lower the
exposures).
These risk estimates suggest that occupational handler risks are largely due to estimated dermal
exposures; the combined dermal and inhalation MOEs were not significantly different from the dermal
MOEs. However, these MOEs are likely to underestimate inhalation exposures. The vapor pressure
of etridiazole is higher than the mean vapor pressure of chemicals in PHED, so actual inhalation risks
are expected to be higher than indicated by the calculated inhalation MOEs. In addition, a chemical-
specific postapplication exposure study in workers handling treated potting soil showed that 70% of the
total dose was due to inhalation. To address the uncertainties associated with inhalation risks, the
Agency is requiring inhalation toxicity and exposure data.
As indicated previously, seven states hold Special Local Need [Section 24(c)] registrations of
Terrazole 35% Wettable Powder for use on tobacco. These registrations were granted between
March and June, 2000. Risks associated with this use site have not been explicitly considered in this
risk assessment and reregistration eligibility decision. However, based on label application rates and
directions for use on the 24(c) labels, the Agency believes that occupational risks are within the range
of those contained in this risk assessment, and are addressed by mitigation agreed to by the registrant.
Handler risk estimates are summarized in Table 9 below. The mitigation measures needed to bring risk
estimates to a level that are not of concern are also indicated.
1) Seed Treatment
Mixing/loading
Mixing/loading emulsifiable concentrate (EC) and flowable concentrate (FC) for on-farm treatment
at all application rates results in MOEs greater than 100 when single-layer clothing is used. However,
single-layer clothing and chemical-resistant gloves were needed to bring cancer risks to a level that is
not of concern. See Table 9, Scenario 3b.
24
-------
Mixing/loading/applying
Loading/applying EC and FC for commercial seed treatment at the typical application rate with single-
layer clothing and chemical-resistant gloves results in cancer risks between 10"4 and 10"5. At the high
application rate, with single-layer clothing and chemical-resistant gloves, the intermediate-term MOE is
42. The effects of adding PPE could not be quantitatively assessed because suitable data were not
available. See Table 9, Scenario 3c.
Handling and bagging for commercial seed treatment with EC and FC results in MOEs greater than
100 when single-layer clothing is used. However, chemical-resistant gloves were needed to bring
cancer risks to a level that is not of concern. See Table 9, Scenario 3d.
Loading dust for commercial seed treatment at the typical application rate, with engineering controls,
results in a cancer risk estimate of 10"5. See Table 9, Scenario 4.
Mixing/loading/applying dust for on-farm seed treatment with single-layer clothing and chemical-
resistant gloves results in an intermediate-term MOE of 45 and cancer risk for commercial applicators
of 10"4. The effects of adding PPE could not be quantitatively assessed because suitable data were not
available. See Table 9, Scenario 8.
2) Golf Course Use
Mixer/loaders, applicators, mixer/loader/applicators
Mixing/loading wettable powder for groundboom application to 40 acres (golf course tees, greens and
fairways) results in MOEs ranging from 7 to 87 and cancer risks between 10"4 and 10"5 with coveralls,
chemical-resistant gloves, and OV respirator. See Table 9, Scenarios la, 5a, and 14. Use of
engineering controls results in MOEs of 100 or greater but cancer risks remain of concern.
These scenarios, la, 5a and 14, were also assessed assuming application to tees and greens only, thus
reducing the acres treated to 5 acres. MOEs range from 56 to 6400 with maximum PPE; cancer risks
are between 10"5 and 10"8.
Mixing/loading wettable powder for chemigation for use on turf results in MOEs greater than 100
when single-layer clothing and chemical-resistant gloves are used. However, single-layer clothing,
chemical-resistant gloves, coveralls and an OV respirator were needed to bring cancer risks to a level
that is not of concern. See Table 9, Scenario Ib.
Loading/applying granules to turf with a belly grinder at the typical application rate using maximum
PPE results in margins of exposure of 35 (short-term) and 13 (intermediate-term) and cancer risks
25
-------
between 10"4 and 10"6. Loading/applying granules to turf with a push-type spreader at the typical
application rate using maximum PPE results in margins of exposure of 53 (short-term) and 20
(intermediate-term) and cancer risks between 10"4 and 10"5. See Table 9, Scenarios 11 and 12.
Loading/applying granules to turf using a tractor-pulled spreader with single-layer clothing results in
MOEs greater than 100 and cancer risks that are not of concern. See Table 9, Scenario 13.
3) Nursery Use
Mixing/loading/'applying
Mixing/loading/applying granules in-furrow to nursery soil with single-layer clothing results in MOEs
and cancer risks that are not of concern. See Table 9, Scenario 6.
Mixing/loading/applying EC in-furrow to nursery soil with single-layer clothing results in intermediate-
term MOEs of less than 100 and cancer risks that are of concern. With the additional of chemical-
resistant gloves, MOEs and cancer risks are not of concern. See Table 9, Scenario 7.
Mixing/loading/applying EC as a drench with a low-pressure handwand using single-layer clothing
results in intermediate-term MOEs less than 100 and cancer risks less than 10"6. With the addition of
chemical-resistant gloves, MOEs and cancer risks are not of concern. See Table 9, Scenario 9.
Mixing/loading/applying EC as a drench with a high-pressure handwand using coveralls over single-
layer clothing, chemical-resistant gloves and an OV respirator results in commercial cancer risks of 10"
5. See Table 9, Scenario 10.
Loading/applying granules with a belly grinder, power dust blower and push-type spreader with
coveralls over single-layer clothing, chemical-resistant gloves and an OV respirator results in margins of
exposure ranging from 4 to 15 and cancer risks of 10"4. See Table 9, Scenarios 17-20.
Loading/applying granules (3% ai formulation) with a tractor-drawn spreader at the maximum
application rate with single-layer clothing results in MOEs greater than 100 and cancer risks of that are
not of concern. See Table 9, Scenario 21.
Loading/applying granules (5% ai formulation) with a tractor-drawn spreader at the maximum
application rate with single-layer clothing results in cancer risks of 10"5. With the addition of chemical-
resistant gloves, cancer risks are 10"6. See Table 9, Scenario 22.
26
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Loading/applying granules with a power dust blower could not be quantitatively assessed because no
data are available for assessing this scenario. See Table 9, Scenario 23.
Applying granules by hand with maximum PPE results in margins of exposure of 13 (short-term) and
4.9 (intermediate-term) and cancer risks of 10"5. See Table 9, Scenario 24.
4) Greenhouse/Potting Soil Use
Mixing/loading/applying
Mixing/loading/applying granules to potting soil with single-layer clothing results in MOEs and cancer
risks that are not of concern. See Table 9, Scenario 15.
Mixing/loading/applying wettable powder to potting soil with single-layer clothing results in MOEs that
are not of concern, but cancer risks greater than 10"6. With the addition of chemical-resistant gloves,
cancer risks are not of concern. See Table 9, Scenario 16.
4) Cotton Use
Mixing/loading
Loading granules for in-furrow application to cotton with single-layer clothing results in MOEs greater
than 100 and cancer risks that are not of concern. See Table 9, Scenario 2.
Mixing/loading EC for in-furrow application to cotton with single-layer clothing results in MOEs and
cancer risks less than 100. With the addition of chemical-resistant gloves, MOEs and cancer risks are
not of concern. See Table 9, Scenario 3a.
Mixing/loading/applying
Applying EC for in-furrow application to cotton with single-layer clothing results in MOEs greater than
100 and cancer risks that are not of concern. See Table 9, Scenario 5b.
27
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Table 9. Summary of Risk Estimates for Etridiazole Handlers
Exposure Scenario
Crop Type
or Target
Acres
Treated or
Gal./
Application
Application
Rate
Combined MOEs1
(dermal and
inhalation)
ST2
Target
100
IT3
Target
100
Lifetime Cancer
Private
Commercial
Occupational Mixer/Loader
(la) mixing/loading
wettable powder for
groundboom application
(Ib) mixing/loading
wettable powder for
chemigation
(2) loading granular for
in-furrow application
(3a) mixing/loading
EC/FC for in-furrow
application
(3b) mixing/loading
EC/FC for on-farm seed
treatment
(3c) loading/applying
EC/FC for commercial
seed treatment (Uniroyal
study)
turf/
golf course
40 acres
(tees,
greens,
fairways)
turf/
golf course
2 acres
cotton
80 acres
cotton
80 acres
peanuts
80 acres
cotton
80 acres
seed
330K Ibs
low
typical
high
low
typical
high
Uniroyal
estimate
typical
high
Uniroyal
estimate
typical
high
low
typical
high
Uniroyal
estimate11
high
876
12007
436
5907
226
2907
3104
1604
HO4
19004
46004
29004
13005
24005
12005
5504
2804
3504
2705
no5
326
4407
166
2207
86
no7
1204
11005
7205
7204
17004
11004
4805
9105
4605
2104
1004
1304
1005
42 5,8
NE10
6.8xlO'5 6
S.OxlO'6 7
NE10
NE10
4.0x1 0'7 6
NE10
3.0xlO'7 4
3.8xlO'7 4
NE10
4.5xlO'7 5
7.2x1 0'7 5
NE10
NE10
1.2xlO'7 5
NE10
4.3xlO-5 5'8
NE10
NE10
2.0xlO'4 6
l.SxlO'5 7
NE10
NE10
4.0x1 0'6 6
NE10
l.SxlO'6 4
l.SxlO'6 4
NE10
2.3X10'6 5
2.9X10'6 5
NE10
NE10
3.5xlO'7 5
NE10
1.3xlO-4 5'8
NE10
28
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Exposure Scenario
(3d) seed
handler/bagger: EC/FC
for commercial seed
treatment (Uniroyal
study)
(4) loading dust for
commercial seed
treatment
Crop Type
or Target
Acres
Treated or
Gal./
Application
seed
330K Ibs
seed
330K Ibs
Application
Rate
Uniroyal
estimate11
high
low
typical
high
Combined MOEs1
(dermal and
inhalation)
ST2
Target
100
12004
4804
2005
1005
406
5407
IT3
Target
100
4304
ISO4
1206
606
8007
156
2007
Lifetime Cancer
Private
1.6xlO-6 5>8
NE10
NE10
7.3xlO'5 6
5.4X10'6 7
NE10
Commercial
4.8X10'6 5'8
NE10
NE10
2.2X10'4 6
1.6X10'5 7
NE10
Occupational Applicator
(5a) applying WP with
groundboom sprayer
(5b) applying EC/FC in-
furrow
(6) mixing/loading/
applying granules in-
furrow
turf/
golf course
40 acres
(tees,
greens,
fairways)
cotton
80 acres
soil
80 acres
low
typical
high
Uniroyal
estimate
typical
high
Uniroyal
estimate
typical
high
8004
4004
2004
21004
40004
20004
9204
18004
14004
2404
1504
1006
7704
15004
7504
3404
6604
5204
NE10
5.5xlO-6 6
2.5X10'6 7
NE10
2.8xlO'7 4
4.4xlO'7 4
NE10
6.4x1 0'7 4
9.9xlO'7 4
NE10
NE10
1.6xlO-5 6
7.6X10'6 7
NE10
2.0X10'6 4
l.SxlO'6 4
NE10
3.2X10'6 4
4.0X10'6 4
NE10
Occupational Mixer/Loader/Applicator Estimates
(7) mixing/loading/
applying EC/FC in-
furrow
soil
80 acres
low
typical
1204
1604
7205
9605
NE10
6.8xlO'7 5
NE10
2.7x1 0'6 5
29
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Exposure Scenario
(8) mixing/loading/
applying (dry) in planter
box
(9) mixing/
loading/applying EC/FC
as drench using low
pressure handwand
(10) mixing/
loading/applying EC/FC
as drench using high
pressure handwand
(11) loading and
applying granules using
belly grinder
(12) loading and
applying granules using
push-type spreader
(13) loading and
applying granules using
tractor-pulled spreader
( 14)mixing/loading/
applying WP using
groundboom
(15) mixing/load-
ing/applying granules
Crop Type
or Target
Acres
Treated or
Gal./
Application
seed
1440 Ibs
soil
5,000 s.f. -
0.5 acres
soil
1000 gallons
turf/
golf course
1 acre
turf/
golf course
5 acres
turf/
golf course
5 acres
turf/
golfcourse
40 acres
(tees,
greens and
fairways)
potting soil
10 cubic
yards
Application
Rate
high
high
typical
high
typical
typical
typical
low
typical
high
typical
Combined MOEs1
(dermal and
inhalation)
ST2
Target
100
13005
1205
1404
3204
356'9
536,9
34004
646
6007
406
3807
206
1907
290,0004
IT3
Target
100
4805
455,8
12,0005
1204
136,9
206'9
13005
246
2307
156
1407
76
717
110,0004
Lifetime Cancer
Private
NE10
3.4X10'6 5>8
5.6xlO-8 5
3.5xlO-6 6>9
l.VxlO'5 6'9
l.lxlO'5 6'9
6.8xlO'7 4
NE10
7.3xlO-5 6
V.SxlO'6 7
NE10
6.2xlO-94
Commercial
NE10
l.OxlO'4 5'8
5.6x1 0'7 5
3.5xlO-5 6'9
l.VxlO'4 6'9
l.lxlO'4 6'9
2.0x1 0'6 4
NE10
l.SxlO'4 6
1.6X10'5 7
NE10
1.9xlO-8 4
30
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Exposure Scenario
(16) mixing/loading/
applying WP
(17) loading/applying
granules (8G) with a
belly grinder
(18) loading/applying
granules (5G) with a
belly grinder
(19) loading/applying
granules (5G) with a
push-type spreader
(20) loading/applying
granules (8G) with a
push-type spreader
(21 )loading/applying
granules (8G) with a
tractor-pulled spreader
(22) loading/applying
granules (5G) with a
tractor-pulled spreader
(23) loading/applying
granular via power dust
blower8
(24) dispersing granules
by hand
Crop Type
or Target
Acres
Treated or
Gal./
Application
potting soil
10 cubic
yards
soil
1 acre
soil
1 acre
soil
acre
soil
1 acre
soil
soil
5 acres
no data
soil
5000 s.f.
Application
Rate
typical
maximum
maximum
maximum
maximum
maximum
maximum
no data
Combined MOEs1
(dermal and
inhalation)
ST2
Target
100
3704
96,9
146,9
156'9
156,9
10004
8904
no data
136-9
IT3
Target
100
1404
49
Commercial
8.6x1 0'7 5
5.3xlO-4 6'9
5.9xlO-4 6-9
3.9X10'4 6'9
3.4xlO-4 6'9
5.3x1 0'64
6.0x1 0'6 5
no data
7.4x1 0'5 6'9
'Combined MOEs are dominated by dermal exposure.
2Short-term (<7 days)
3Intermediate-term (8 days to several months)
4This risk estimate reflects baseline protection (single-layer clothing).
5This risk estimate reflects single-layer clothing plus chemical-resistant gloves.
31
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6This risk estimate reflects coveralls over clothing, chemical-resistant gloves, organic-vapor-removing (OV)
respirator.
7This risk estimate reflects the use of engineering controls, i.e. water-soluble bag or closed system.
8No data are available for assessing the effects of engineering controls on this scenario.
'Engineering controls do not or are not known to exist for this scenario.
10Not evaluated; cancer risks are estimated only at typical application rate.
"Closely approximates typical application rate.
For more information on the occupational risks, see the Occupational Exposure and Risk Assessment
section of the June 6, 2000 Human Health Risk Assessment.
d. Occupational Postapplication Exposure and Risk
Occupational postapplication scenarios assessed for etridiazole include greenhouse or nursery workers
handling treated potting soil, golf course workers engaged in turf maintenance, and farmers handling
treated seed for planting. Based on the etridiazole use pattern, there is potential for short- and
intermediate-term postapplication exposure to etridiazole residues for workers associated with turf,
cotton, seed treatment and potting soil uses. In addition, long-term exposure could occur for
postapplication greenhouse/nursery workers handling treated potting soil. MOEs of 100 or greater for
short- and intermediate-term postapplication exposure and 300 or greater for long-term postapplication
exposure are not of concern.
Postapplication dermal risks for golf course workers are summarized in Table 10. Only short- and
intermediate-term risks were estimated; long-term exposure is not expected. These risk estimates were
derived from etridiazole-specific magnitude of residue and transfer of residue studies from golf courses.
These risk estimates are not of concern, as long as the current restricted entry interval (REI) of 12
hours is observed.
32
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Table 10. Dermal Risk Estimates for Postapplication Golf Course Workers
Exposure Scenario
Tractor
Mowing
Push-
mowing
after
application
after 12
hours
after
application
after 12
hours
Residue
(ug/cm 2)
0.13
0.054
0.13
0.054
Transfer
Factor
(cm2/hr)
500
500
1000
1000
ST2MOE
Target 100
3500
9000
1700
4500
IT3MOE
Target 100
1300
2800
650
1400
Cancer Risk
2.0 xlO'5
2.8 xlO'6
4.0 xlO'5
5.6 xlO'6
'Based on Gaydosh, K., 1994. MRID No. 432878-01 and 432878-02.
2 Short-term
3Intermediate-term
4A11 study data support turf transferrable residues <0.05 ug/cm2 at 12 hours after application; therefore this
represents an upper-bound estimate.
Postapplication risks for greenhouse and nursery workers are summarized in Table 11. Short-,
intermediate- and long-term risks were estimated. These risk estimates are derived from a high quality
study measuring dermal and inhalation exposures to etridiazole in a greenhouse setting. Because
workers participating in the study were engaged in potting treated soil without the use of gloves at the
highest label application rate for four hours, these risk estimates are expected to be conservative and
protective for other soil-contact activities as well. The margins of exposure are not of concern, as long
as the current restricted entry interval (REI) of 12 hours is observed. Cancer risks, however, remain
greater than IxlO"6 even after 24 hours.
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Table 11. Dermal and Inhalation Risks for Postapplication Nursery Workersl
Exposure Scenario
Potting/
handling
treated
soil
after 12
hours
after 24
hours
Total
Residue
(mg/cm2) 2
0.375
0.54
Transfer
Factor
(cm2/hr)
NA6
NA
ST3MOE
Target 100
2400
1700
IT4MOE
Target 100
900
530
LT5 MOE
Target 300
900
530
Cancer
Risk
2.9 xlO'5
6.0 xlO'5
'Belcher et al., 1997, MRID No. 442787-01
2mg/4 hour day from study
3Short-term
4Intermediate-term
5Long-term
6Not applicable
Postapplication dermal risks for farmers handling and planting treated seed are summarized in Table 12.
Only short- and intermediate-term risks were estimated; long-term exposures are not expected. No
chemical-specific data were available for seed handling scenarios, so exposure was estimated by
assuming that the total amount of etridiazole applied to the seed is available. These risk estimates are
not of concern as long as current REIs are observed.
Table 12. Dermal Exposure Risks for Farmers Handling Treated Cottonseed
12 Hours Post-Application1
Formulation
Dust
Liquid
Application
Rate2
0.05
0.0625
Combined MOE
(Dermal + Inhalation)
ST3
60,000
48,000
IT4
22,000
18,000
Cancer Risk
Private Farm5
6.8 xlO'8
8.4 xlO'8
Commercial'
2.0 x lO'7
2.4 x 10'7
'Due to the lack of data for seed treatment, this assessment assumed the total amount of etridiazole applied to the
seed is available. Unit exposure data for handling granular formulations from PHED were used to estimate the dose.
2lb ai/100 Ib cotton seed
3Short-term (<7 days)
4Intermediate-term (8 days to several months)
57-day exposure duration
620-day exposure duration
34
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d. Incident Reports
Incidents involving exposure to etridiazole are reported in the four sources reviewed: OPP's Incident
Data System (IDS), Poison Control Centers (PCC), California Department of Pesticide Regulation
(CDPR), and the National Pesticides Telecommunications Network (NPTN).
Relatively few incidents involving injury from etridiazole have been reported. In one incident, a
greenhouse worker potting soil as part of an exposure study reportedly became ill after handling treated
soil four hours after treatment (rather than twelve hours as indicated on the label). Poison Control
Center data from 1993 through 1996 indicate that the percentage of etridiazole exposure cases seen in
a health care facility was only slightly above the average for all pesticides. The California Pesticide
Illness Surveillance Program has received one report of illness in which etridiazole was judged to be
responsible. In this case, a worker handling moist treated soil reportedly experienced eye and skin
illness for two years but did not require hospitalization and was not known to take time off work due to
the exposure.
B. Environmental Risk Assessment
A summary of the Agency's environmental fate and effects risk assessment is presented below. More
detailed information on the environmental and ecological risks associated with the use of etridiazole may
be found in the Revised EFED Risk Assessment for the Reregistration Eligibility Decision on 5-
ethoxy-3-trichloromethyl-l,2,4-thiadiazole (Etridiazole; Terrazole®), May 16, 2000. Since that
document was completed, the Agency made changes in its assessment of chronic surface water
concentrations of etridiazole associated with turf use. Specifically, the Tier 1 GENEEC simulation was
refined to reflect use on tees, greens and fairways only rather than an entire golf course. This revision
is described in the memorandum entitled Terrazole: Refined Tier I Chronic Surface Water EECsfor
Use in the Human Health Drinking Water Risk Assessment, May 26, 2000. The complete
environmental fate and effects risk assessment and related addenda are not included in this document,
but are available on the Agency's web page at www.epa.gov/pesticides, and in the Public Docket.
1. Fate and Transport
Etridiazole is a mobile compound with moderate persistence; these properties generally would raise
concern related to the quality of groundwaters and surface waters in the proximity of treated crops.
Given the low application rates for cotton, ornamental plants and seed treatment, the chemical has
relatively low potential to affect the quality of such bodies of water as a result of these uses. However,
turf use presents a different scenario because the application rates are very high (50 times higher than
35
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for the other crops, up to an annual maximum total of 19 Ib a.i./A) and golf courses represent
particularly vulnerable use sites prone to contamination of surface waters via runoff.
The primary route of dissipation of etridiazole is volatilization and to a lesser degree aerobic soil
metabolism. It is stable to hydrolysis and aqueous photolysis; however, it is somewhat susceptible to
soil photolysis. Under aerobic soil metabolism conditions, etridiazole dissipates slowly. Two
degradation products, 3-Carb-T and 3-DCMT, were observed in the soil photolysis and the aerobic
soil metabolism studies to have properties similar to that of the parent compound.
Terrestrial field dissipation studies show that etridiazole has low to moderate persistence, with
dissipation rates that appear to suggest substantial volatilization. The moderate rate of dissipation of
etridiazole in the field suggests the potential for contamination of both surface and ground waters if the
appropriate environmental conditions are present. The variability in the half-lives (4-33 days) seen in
terrestrial field dissipation studies conducted in Texas, North Carolina and California is consistent with a
compound that volatilizes.
Etridiazole may reach surface waters following rain events that produce runoff a few days to weeks
after application (for two of the terrestrial field dissipation studies, the half-lives were 16 and 33 days).
Since etridiazole is relatively stable to abiotic degradation (hydrolysis, aqueous photolysis), it may
persist for considerable periods of time in aquatic areas with long residence times and low
microbiological activity. Additionally, volatilization from water may or may not be significant depending
on environmental conditions such as depth of the water, temperature, wind speed and flow rate. The
actual rate of volatilization from aqueous environments is relatively slow, with a half-life of 25 days.
Two degradates (3-Carb-T and 3-DCMT) detected in laboratory studies were monitored in the field.
Both degradates had high mobility in laboratory batch equilibrium studies. In the field, the degradate 3-
Carb-T was persistent and mobile relative to the parent compound. The degradate 3-DCMT
appeared to be somewhat persistent, but it did not leach substantially.
Etridiazole accumulated in fish with bioconcentration factors (BCFs) of 94x in edible fish tissues, 328x
in viscera, and 193x in whole fish. Depuration was rapid, at 50% one day after ending exposure.
For more environmental fate and transport information on etridiazole, see the Environmental Fate
Assessment section of the May 22, 2000 Environmental Fate and Effects Risk Assessment.
36
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2. Water Resources
Risks to aquatic organisms were estimated using the same EECs used in the drinking water assessment,
as shown in Table 7, with the exception of chronic surface water concentrations associated with
application to turf. The chronic surface water EEC for turf use originally assumed application to an
entire golf course. The calculation was later refined to reflect use on greens, tees and fairways only,
resulting in a lower chronic EEC for turf of 32.3 ppb. This EEC is reflected in the chronic aquatic risk
quotients cited below. For more information, see Terrazole: Refined Tier I Chronic Surface Water
EECs for Use in the Human Health Drinking Water Risk Assessment, May 26, 2000.
3. Ecological Risks
To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity studies
using the quotient method. Risk quotients (RQs) are calculated by dividing exposure estimates by
ecotoxicity values, both acute and chronic, for various species. The higher the RQ the greater the
concern. Risk characterization provides further information on the likelihood of adverse effects
occurring by considering the fate of the chemical in the environment, communities and species
potentially at risk, their spatial and temporal distributions, and the nature of the effects observed in
studies. For more information on the ecological risks posed by the use of etridiazole, see the Ecological
Effects Hazard Assessment and Ecological Risk Assessment sections of the Revised EFED Risk
Assessment for the Reregistration Eligibility Decision on 5-ethoxy-3-trichloromethyl-1,2,4-
thiadiazole (Etridiazole; Terrazole®), May 22, 2000.
The ecological toxicity database for etridiazole is incomplete. Available data indicate that on an acute
basis, etridiazole is practically nontoxic to birds, slightly toxic to mammals, moderately toxic to fish and
aquatic invertebrates, and highly toxic to aquatic plants. On a chronic basis, etridiazole produced
reproductive and growth effects in birds, fish and aquatic invertebrates. Acceptable chronic toxicity
data for mammals measuring reproductive effects have not been submitted by the registrant, so a
chronic risk assessment for mammals could not be conducted.
Golf course turf use is expected to pose a risk to surface water quality given the relatively high
application rates for turf and the likelihood that golf course runoff will move to surface water.
Etridiazole may also reach surface waters as a result of spray drift.
a. Risks to Birds
For cotton use, avian acute RQs range from <0.01 to 0.06; chronic RQs range from 0.06 to 1.82.
After one application at the typical rate for turf, acute RQs range from 0.03 to 3.5. After two and five
37
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applications at the typical rate for turf, chronic risks are of concern for birds feeding on all food items,
with RQs ranging from 0.1 to 64.
In a chronic toxicity study in mallards, significant reproductive effects including reduced numbers of
eggs laid, viable embryos, normal hatchlings and 14-day survivors were observed. A chronic toxicity
study in bobwhite quail yielded similar results. It is uncertain whether these reproductive effects are
indicative of an endocrine-mediated mode of action.
b. Risks to Mammals
After application to cotton, there are no acute risk concerns for mammals.
For turf use, acute RQs range from 0 to 2.95. After one application at the typical application rate for
turf, there are acute risk concerns for small, intermediate and large mammals feeding on short grasses,
tall grasses, broadleaf plants and insects. After two and five applications at the typical application rate
for turf, there are acute risks for small, intermediate and large mammals feeding on short and tall grass,
broadleaf plants and insects.
An assessment of chronic risks to mammals could not be conducted due to lack of appropriate toxicity
data. Chronic mammalian toxicity data that will enable this assessment are being required, as discussed
in Section V.A.2, Additional Generic Data Requirements, of this document.
c. Risks to Fish and Aquatic Invertebrates
Etridiazole is moderately toxic on an acute basis to both freshwater and marine fish and invertebrates.
Available chronic data indicate that etridiazole produced growth effects in freshwater fish.
After application to cotton, there are no risk concerns for freshwater fish and invertebrates or for
estuarine/marine fish and invertebrates.
For turf use, the acute RQs for freshwater fish range from 0.188 to 0.361; chronic RQs range from
1.41 to 2.70. For freshwater invertebrates, acute RQs are 0.05 to 0.09; chronic RQs are 0.55 to
1.05. For estuarine/marine fish, acute RQs are 0.06 to 0.11. For estuarine/marine aquatic
invertebrates, acute RQs are 0.09 to 0.18. Chronic RQs were not calculated for estuarine/marine fish
and invertebrates because appropriate chronic toxicity data were not available.
38
-------
The degradate 3-DCMT was found to be very highly toxic to freshwater fish on an acute basis. No
toxicity data are available for the degradate 3-Carb-T; however, based on its partition coefficient, 3-
Carb-T is expected to be less toxic to aquatic organisms than 3-DCMT.
d. Risks to Aquatic Plants
Etridiazole was classified as highly toxic to non-target aquatic plants. Toxicity to green algae was
approximately 100 times higher than other aquatic plants tested. Acute risk concerns exist at the typical
application rates for turf, with RQs ranging from 0.03 to 218.00. Chronic risks were not estimated
because chronic toxicity tests are not available for aquatic plants.
e. Risks to Endangered Species
There are risks to federally listed endangered and threatened birds, mammals, aquatic plants and
freshwater and estuarine fish and invertebrates from single and multiple applications of etridiazole to
turf.
IV. Risk Management, Reregistration and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data
concerning an active ingredient, whether or not products containing the active ingredient are eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e.,
active ingredient-specific) data required to support reregistration of products containing etridiazole as
an active ingredient. The Agency has completed its review of these generic data, and has determined
that the data are sufficient to support reregistration of all products containing etridiazole. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of etridiazole.
These data were sufficient to allow the Agency to determine that etridiazole can be used without
resulting in unreasonable adverse effects to humans and the environment. The Agency, therefore, finds
that all products containing etridiazole as the active ingredient are eligible for reregistration, provided
specified changes are made to the label. Actions needed to reregister particular products are
addressed in Section V of this document The Agency believes that these label changes address the
current risk estimates and reflect the use of all acceptable data available at this time together with
uncertainty factors and where data gaps exist.
39
-------
In addition to the label changes specified in Section V, the registrant plans to submit data to
demonstrate that surface water concentrations are not a concern and a second cancer study to more
fully characterize the carcinogenic potential of etridiazole. If water data show that exposure is not of
concern, and the cancer study shows no increased carcinogenic potential above that already estimated
based on the rat study, then fairway use may be returned to product labels. If either the water data
shows increased risk estimates or the cancer study shows increased carcinogenic potential, the
registrant has agreed to voluntarily cancel the use on fairways. The registrant has also agreed to reduce
the maximum application rate on golf course tees and greens, and to reduce the maximum amount
applied per season.
The Agency may take appropriate regulatory action if new information comes to the Agency's attention
regarding the reregistration of etridiazole. The Agency may also require the submission of additional
data (1) to support the registration of products containing etridiazole, (2) if the data requirements for
registration change, or (3) if the guidelines for generating such data change.
B. Tolerance Reassessment
Based on the review of the generic data for etridiazole, the Agency has sufficient information to reassess
tolerances for etridiazole. Specific findings are discussed in the following section.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for etridiazole, with amendments and changes as
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(D) of the FFDCA, that there is a reasonable certainty of no harm for the general population.
In reaching this determination, EPA has considered all available information on the toxicity, use
practices and scenarios, and the environmental behavior of etridiazole. Since there are no residential or
lawn uses of etridiazole, no dermal or inhalation exposure is expected in and around the home. The
only non-occupational exposure source is treated golf courses, and only short-term exposures are
expected to occur. Therefore, EPA has considered only acute, chronic (non-cancer), and chronic
(cancer) exposures from dietary (food and drinking water) and short-term non-occupational golf course
exposures in its aggregate risk assessments.
40
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Aggregate Dietary Risks: Acute and chronic non-cancer dietary risks (food and water) are not of
concern for any population subgroup, and no mitigation is necessary.
Chronic cancer dietary risks are a concern for the general population due to chronic surface water
EECs associated with use on golf course tees, greens and fairways. For the cancer dietary risk
assessment, the Agency has estimated the cancer dietary (food) risk to be 1.6 x 10"7 for uses supported
through reregistration. The registrant has agreed to remove fairway use from product labels, to reduce
the maximum application rate on golf course turf, to reduce the frequency of application, and to reduce
the maximum number of pounds allowed to be applied per season. In addition, the registrant plans to
provide additional data to refine exposure and carcinogenicity estimates. The reductions in area
treated, and frequency and amount applied reduce the estimated chronic surface water EEC for turf use
to 5 ppb, compared to a DWLOC of 1 ppb. Given that the DWLOC and EEC are derived from
models using conservative exposure assumptions, and that dietary (food only) cancer risks for the
general population are less than the amount the Agency considers to be negligible, the Agency does not
believe that the chronic surface water EEC of 5 ppb is a risk of concern, as discussed in Section
IV.E. 1 .d. EPA is reasonably certain that exposure to etridiazole in drinking water will result in no harm.
Short-term Aggregate Risk: Cancer aggregate risk estimates for the general population are of
concern due to surface water EECs from use on golf course tees, greens and fairways. These estimates
include chronic exposure to food and water and short-term non-occupational exposure to treated golf
courses. The combined cancer risk estimate for food and golf course exposure, including fairways, was
1. 1x10"6. The registrant has agreed to remove fairway use from product labels as well as to reductions
in the application rates, maximum poundage applied per season and the frequency of application, which
adequately address the drinking water contribution to aggregate risk. With the reductions in area
treated and amount applied discussed above and the incorporation of a new (increased) transfer
coefficient derived from data obtained from the Agricultural Reentry Task Force, the cancer risk
estimate for food and golf course exposure combined is 1.3xlO"6. This risk estimate is based on
conservative, or protective, assumptions about exposure from both food and golf courses, as discussed
in Section V.D.S.d. The Agency does not believe this represents a risk of concern. EPA is reasonably
certain that aggregate exposure to etridiazole will result in no harm.
b. Determination of Safety for Infants and Children
EPA has determined that the established tolerances for etridiazole, with amendments and changes as
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children.
The safety determination for infants and children considers the factors noted above for the general
population, but also takes into account the possibility of increased dietary exposure due to the specific
41
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consumption patterns of infants and children, as well as the possibility of increased susceptibility to the
toxic effects of etridiazole residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic effects from
etridiazole residues, EPA considered the completeness of the database for developmental and
reproductive effects, the nature of the effects observed, and other information. An FQPA safety factor
is required for etridiazole because there is no acceptable multigeneration reproduction study which
could identify potential reproductive effects to the parental animals or to the offspring following pre-
/postnatal exposure to etridiazole. However, the FQPA Safety Factor Committee concluded that the
lOx FQPA safety factor could be reduced to 3x for the reasons discussed earlier in Section ni.A.3.
The FQPA safety factor of 3x is used in the chronic dietary risk assessment only and is applicable to all
population subgroups.
c. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such
endocrine effects as the Administrator may designate." Following recommendations of its Endocrine
Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was
scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA
include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the
extent that effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening Program
(EDSP).
When the appropriate screening and/or testing protocols being considered under the EDSP have been
developed, etridiazole may be subject to additional screening and/or testing to better characterize
effects related to endocrine disruption.
d. Cumulative Risks
The Food Quality Protection Act requires that, when considering whether to establish, modify, or
revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common mechanism of toxicity." The
Agency is examining whether and to what extent thiazole pesticides share a common mechanism of
42
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toxicity. Current information on the common mechanism of toxicity for thiazoles is limited, and the
Agency's understanding of this relationship needs to be further developed. As a result, the Agency has
not determined if it would be appropriate to include them in a cumulative risk assessment with other
thiazoles or carcinogenic chemicals. Therefore, for the purposes of this risk assessment, the Agency
has assumed that etridiazole does not share a common mechanism of toxicity with other thiazoles or
carcinogenic chemicals.
D. Tolerance Summary
The established tolerances for residues of etridiazole in/on plant commodities are currently expressed in
terms of etridiazole and its monoacid metabolite, 3-Carb-T. Tolerances are established in or on the
following raw agricultural commodities: corn, cottonseed, tomatoes, wheat, strawberries, meat, milk,
poultry, and eggs (40 CFR §180.370). Etridiazole is not currently registered for use on tomatoes or
strawberries. The tolerance for strawberries is no longer being supported by the registrant and will be
revoked. The registrant has committed to provide additional data in order to maintain the tolerance for
tomatoes for import purposes.
The Agency has updated the list of raw agricultural and processed commodities and feedstuffs derived
from crops (Table 1, OPPTS GLN 860.1000). As a result of these changes, etridiazole tolerances for
certain commodities which have been removed from the list will be revoked. In addition, tolerances for
commodities which will not be supported for reregistration will be revoked. A summary of etridiazole
tolerance reassessments is presented in Table 13.
1. Tolerances Listed Under 40 CFR §180.370
Sufficient data have been submitted to reassess the established tolerances for the following plant
commodities: corn, cottonseed and wheat. The available data from field trials on cotton reflecting the
maximum registered use patterns suggest that the combined residues of etridiazole and its monoacid
metabolite in/on undelinted cottonseed can be lowered to 0.1 ppm. Available residue data support the
tolerances at 0.1 ppm for residues in/on corn forage and fodder and wheat forage and straw.
The use of etridiazole on strawberries and tomatoes is not being supported for reregistration, and these
sites do not appear on any of Uniroyal's end-use product labels that contain etridiazole as an active
ingredient. Uniroyal has committed to support a tolerance for tomatoes for import purposes but not for
strawberries. Consequently, the tolerance for strawberries will be revoked. Unless Uniroyal or
another entity submits acceptable foreign field trial data as required to support the tolerance on
tomatoes for import purposes, the established tolerance for tomatoes will be revoked.
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Established tolerances in all animal commodities will be revoked. Available data suggest no reasonable
expectation of finite residues (Category 3 of 40 CFR §180.6) of etridiazole and 3-Carb-T in meat,
meat by-products, fat and milk of cattle, goats, hogs, horses, sheep, and in poultry, poultry fat, poultry
meat by-products, and eggs. Available data suggest that even when etridiazole was applied to cotton
in-furrow at 100 times the maximum application rate, there were no residues of parent or metabolite in
cottonseed or foliage. In addition, data indicate that residues of etridiazole in cotton, undelinted
cottonseed or cotton gin byproducts (livestock feed items) are likely to be less than the limit of
quantitation.
2. New Tolerances to Be Established under 40 CFR §180.370
New tolerances are needed for etridiazole residues in/on the following raw agricultural commodities:
cotton gin byproducts, peanut nutmeat and hay, sorghum grain and forage, barley grain and hay, and
safflower seed. Tolerances are also needed for legume vegetables (succulent or dried), and foliage of
legume vegetables. All new tolerances will be set at 0.1 ppm.
Table 13. Tolerance Summary for Etridiazole
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment
[Correct Commodity Definition]
Tolerances listed under 40CFR § 180.370
Com, field, grain
Corn, fodder
Com, forage
Cotton, seed
Strawberries
Tomatoes
0.05
0.1
0.1
0.2
0.2
0.15
0.1
0.1
0.1
0.1
Revoke
To Be
Determined
Metabolism studies indicate that the tolerance for
residues in/on com grain should be increased to
0.1 ppm.
The available data support lowering the tolerance.
Cotton, undelinted seed
The registrant is no longer supporting use on
strawberries.
Etridiazole is not registered for use on
domestically grown tomatoes. Tolerance to be
determined based on import residue foreign field
trial data (HED SOP 98.6).
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Commodity
Wheat, grain
Wheat, forage
Wheat, straw
Eggs
Milk
Fat, mbyp, and meat of
poultry
Fat of cattle, goats, hogs,
horses, and sheep
Meat and mbyp of cattle,
goats, hogs, horses, & sheep
Current
Tolerance
(ppm)
0.05
0.1
0.1
0.05
0.05
0.10
0.10
0.10
Tolerance
Reassessment
(ppm)
0.1
0.1
0.1
Revoke
Comment
[Correct Commodity Definition]
Available data indicate that the tolerance for
residues in/on wheat grain should be increased to
0.1 ppm.
Available data suggest no reasonable expectation
of finite residues (Category 3 of 40 CFR § 180.6) of
etridiazole and 3-Carb-T in livestock commodities.
Tolerances Needed under 40CFR 180.370
Cotton, gin byproducts
Vegetable, foliage of legume,
group
Legume vegetables
(succulent or dried) crop
group
Barley, grain
Barley, hay
Peanut
Peanut, hay
Safflower seed
Sorghum, grain, grain
Sorghum, forage
None
None
None
None
None
None
None
None
None
None
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
The available data support establishing a
tolerance of 0. 1 ppm for residues in this group.
Available data support establishing a 0.1 ppm
tolerance on this group.
The available data support establishing a
tolerance of 0. 1 ppm for residues in this group.
Available data support a 0. 1 ppm tolerance.
3.
Codex Harmonization
No maximum residue limits for etridiazole have been established by Codex for any agricultural
commodities. Therefore, there are no issues regarding compatibility with respect to U.S. tolerances.
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4. Residue Analytical Methods
Plants: The current Pesticide Analytical Model (PAM) Volume n method is a GLC/ECD method
(designated as Method 1) which is used for analysis of residues of etridiazole^er se and a HPLC/UV
method for determining the monoacid metabolite (designated as Method A) in/on cottonseed, corn and
wheat (Pesticide Reg. Sec. 180.370). PAM Volume n reports the sensitivity of both methods (LOQ)
as 0.05 ppm.
Animals: PAM Volume n does not describe any methods for enforcing tolerances for residues in
animal commodities. However, two Agency-validated methods are available for tolerance
enforcement: a GC/ECD method entitled, "Determination of Residues of Terrazole in Chicken
Matrices," capable of quantitating etridiazole^er se in eggs and beef liver; and a HPLC method
(CAM-47-81) that determines the monoacid in eggs and beef liver. These methods should be included
in future updates of PAM Volume n.
E. Human Health Risk Mitigation
As indicated previously in this document, the Agency is requiring a repeat carcinogenicity study in the
mouse. The available mouse carcinogenicity study was found to be unacceptable due to technical
deficiencies, but it did show the presence of gross and histological lesions in the lung, an organ where
lesions did not occur in the rat study. Although a repeat mouse study had not been required previously,
the Agency is now requiring a repeat of this study in order to confirm the human cancer risk estimates.
Currently, the cancer risk assessment for etridiazole is based upon a relatively high Qx* (3.3 x 10"2) in
the rat. Because the current assessment uses a conservative, or protective, set of human exposure
assumptions for the dietary (food and water), non-occupational (golfer) and occupational assessments,
a second cancer study is expected to confirm the results of this risk assessment and is not likely to
change the outcome of the risk management decisions being made at this time.
1. Dietary Mitigation
a. Acute Dietary (Food)
The acute dietary risk estimate for the only population subgroup of concern, females 13-50, is 1% of
the acute PAD, and thus is not of concern (see Table 3). An acute toxicity endpoint was not identified
for any other population subgroup. Therefore, no mitigation measures are necessary to address acute
dietary risk from food.
b. Chronic (Non-Cancer) Dietary (Food)
Chronic non-cancer dietary risk from food is also not of concern. Chronic non-cancer dietary risk for
the most exposed population subgroup, children 1-6 years of age, is 31% of the chronic PAD; for the
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general U.S. population, exposure estimates account for 14% of the cPAD (see Table 4). These risks
are not of concern; therefore, no mitigation measures are necessary to address chronic dietary risk from
food.
c. Cancer Dietary (Food)
The Agency generally considers IxlO"6 (1 in 1 million) or less to be negligible risk for cancer. The
results of this analysis indicate that the cancer dietary (food only) risk of 1.6 x 10"7 is not of concern
(see Table 5). Therefore, no mitigation measures are necessary to address cancer dietary risk from
food.
d. Dietary (Drinking Water)
Model estimates (EECs) of potential drinking water exposure from ground water sources do not
exceed the acute or chronic (non-cancer and cancer) DWLOC values, and therefore, are not of
concern. Similarly, potential drinking water exposure from surface water after application to cotton
does not exceed the acute or chronic (non-cancer and cancer) DWLOC values, and thus is not of
concern. Potential exposure from surface water sources after application to golf course tees, greens
and fairways is not of concern for acute or chronic (non-cancer) dietary risk. However, potential
exposure from surface water sources after application to golf course tees, greens and fairways is of
concern for chronic (cancer) dietary risk (see Table 6).
The modeled estimate of 56-day average concentrations in surface water associated with use on golf
course fairways, tees and greens is 32.3 ppb. This exceeds the cancer DWLOC of 1 ppb for the
general population, and thus is of concern. To address this risk, the registrant has agreed to
immediately remove use on fairways from product labels, thus limiting use to tees and greens only, to
reduce the maximum application rate to 3.8 Ibs ai/A, increase the minimum interval between
applications to 10 days, and reduce the maximum amount applied per season to 9.6 Ibs ai/A. In
addition, the registrant plans to submit data to demonstrate that surface water concentrations are not a
concern and to more fully characterize the carcinogenic potential of etridiazole. If water data show that
exposure is not of concern, and the second cancer study shows no increased carcinogenic potential
above that already estimated based on the rat study, then fairway use may be returned to product
labels. If either water data shows increased risk from drinking water exposure or the cancer study
shows increased carcinogenic potential, the registrant has agreed to voluntarily cancel the use on
fairways.
When treatment of fairways is removed from the modeled estimates and the reductions in rate,
frequency and seasonal maximum poundage are considered, the surface water concentration is
estimated to be approximately 5 ppb. Despite the fact that the estimated concentrations in surface
water of 5 ppb slightly exceed the estimated DWLOC of 1 ppb, the Agency does not believe this is a
risk of concern for the following reasons:
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1) The EECs were derived from a screening level model (GENEEC) developed for use in
ecological assessments to estimate risks to aquatic organisms. At present, PRZM/EXAMS,
the Tier II model, does not have the appropriate parameters to accurately model turf runoff.
Although GENEEC is not an ideal tool for use in drinking water assessments, it can provide
high-end estimates of the concentrations that might be found in a confined farm pond. Surface
water source drinking water does not typically come from this type of scenario, but rather from
bodies of water that are substantially larger than such ponds and from diverse watersheds.
Unlike a confined pond, there is always some flow (in a river) or turnover (in a lake or a
reservoir) resulting in an overestimation of the persistence of the chemicals near the drinking
water utility intakes. Additionally, contaminated surface water used for drinking water would
undergo dilution and some treatment prior to consumption, likely further reducing the levels of
etridiazole.
2) The GENEEC model uses the 56-day average of pesticide concentrations after the application
of the pesticide, as opposed to the 36-year mean provided by PRZM/EXAMS. This short
time period may not adequately characterize a person's average daily exposure over a year.
3) This EEC is the result of refinements to the GENEEC model. The refinements include the
incorporation of a percent crop area (PCA) factor of 17% as described in Section IH.A.T.a. It
is likely that the assumption that 17% of the area in a watershed is tees and greens is a
conservative assumption. In addition, exposure from application to tees and greens only is not
likely to be widespread.
4) To estimate the DWLOC, exposure from food and non-occupational sources combined are
subtracted from the PAD; the difference represents the theoretical upper limit of exposure from
water in light of total aggregate exposure from food, water and non-occupational uses that will
result in no adverse health effects. To estimate exposures from food, the Agency assumed
residue levels of one-half the combined LOQs for all commodities grown from treated seed
except tomatoes, and tolerance level residues for tomatoes. However, available field trial data
indicate that residues on commodities grown from treated seed are unlikely to occur at current
application rates. Therefore, the amount of exposure from food used in the calculation is likely
an overestimate, with the result that the DWLOC of 1 ppb is likely to be underestimated.
2. Non-occupational Risk Mitigation
a. Non-occupational Non-cancer Risk
The only non-occupational exposure expected to occur is short-term exposure to golfers. For the only
population subgroup of concern, females 13-50 years of age, the MOE is 17,000, which is not a risk
concern. Therefore, no mitigation is necessary.
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b. Non-occupational Cancer Risk
The estimated cancer risk for adult golfers exposed to treated golf course tees, greens and fairways
was 8.9 x 10"7. This calculation, presented in the June 6, 2000, Human Health Risk Assessment.,
used a transfer coefficient of 100. Since that time, the Agency has received data from the Agricultural
Reentry Task Force indicating that a more appropriate transfer coefficient for assessing risk from golf
course exposures is 500. In recalculating the risk to golfers to reflect removal of fairways and therefore
exposure to tees and greens only, the Agency also applied the new transfer coefficient of 500. The
resulting cancer risk estimate for adult golfers exposed to tees and greens only is 1. IxlO"6. This risk
assumes that a golfer who plays golf 18 times per year is exposed 18 times per year, within 12 hours
after application, over a period of 50 years. The Agency believes that the estimated cancer risk is an
overestimate due to these conservative assumptions used in the assessment. A more realistic estimate
assumes that a golfer would likely receive two exposures per year, the typical number of applications of
etridiazole per season. When two exposures are assumed, the resulting cancer risk to golfers is
estimated to be 1.2xlO"7, which is not of concern.
3. Aggregate Risk Mitigation
a. Acute Aggregate Risk
Estimated acute risk for etridiazole for food is 1% of the aPAD, and surface and groundwater acute
EECs are below the DWLOC for the population subgroup assessed (females 13-50 years old). Thus,
acute risk from food and water is not of concern and no mitigation is necessary.
b. Short-term Aggregate Risk
In order to determine the short-term aggregate risk, the Agency combines the short-term risks from any
non-occupational exposures, in the case of etridiazole it is the risk to golfers, with the risks from food
and drinking water. The only short-term toxicity endpoint identified for etridiazole was for females 13
to 50 years of age; consequently, the short-term aggregate risk is calculated only for this
subpopulations. Since the Agency does not have any reliable monitoring data from which to estimate
the exposures in water, it had to rely on the DWLOC method to determine if the risk cup is exceeded.
The short-term risk for golfers (expressed as a margin of exposure) was estimated to be 17,000. The
short-term dietary risk for food for the subpopulations of concern was estimated to be 0.4%, equivalent
to an MOE of 28,000. (The Agency assumes that the chronic exposure from etridiazole residues in
food is equal to the short-term exposure.) By adding the exposures associated with these risks,
comparing them to the short-term lexicological endpoint (i.e., a NOAEL of 15 mg/kg/day), and
determining the amount of room left in the risk cup, one can determine the level of residues in drinking
water that would be allowed (the DWLOC) before the cup is full. In this instance, it was determined
that drinking water could contain up to 4300 ppb before there is a risk of concern (i.e., a margin of
exposure of less than 100). The Agency did not model for short-term exposures from drinking water
49
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but instead used the model estimate for surface water acute exposures for comparison to the DWLOC.
This is a conservative estimate since the level of residues in drinking water to which a person could be
exposed over a short-term period would be expected to be less than the maximum (or acute) level to
which one could be exposed. The short-term DWLOC was estimated to be 4300 ppb, while the
estimated acute exposure was modeled to be 230 ppb. It should be noted that the risk calculated for
the golfer included exposure to fairways. The registrant has agreed to remove fairway use from
product labels which will reduce exposure, increase the MOE and increase the DWLOC. This
coupled with the use of the acute exposure value modeled for drinking water leads the Agency to
believe this is a conservative assessment of short-term aggregate risk. Therefore, short-term aggregate
risks are not a concern, and no mitigation is necessary.
c. Chronic (Non-Cancer) Aggregate Risk
Chronic (non-cancer) aggregate risk for etridiazole includes only food and water exposures. Estimated
risks from food for the most highly exposed subgroup, children 1-6, indicate that 31% of the cPAD is
occupied by dietary (food) exposure and that surface and ground water EECs (32.3 ppb and 0.93
ppb, respectively) are below the chronic DWLOC for this population subgroup (35 ppb). Therefore,
chronic non-cancer aggregate risks are not a concern, and no mitigation is necessary.
d. Chronic Cancer Aggregate Risk
Cancer aggregate risk is a concern for the general population due to surface water EECs associated
with turf. Estimated cancer risk from food and exposure to treated golf courses, including fairways,
was 1. 1x10"6. The registrant has agreed to immediately remove fairway use from labels, reduce the
maximum application rate, the maximum poundage applied per season, and the frequency of
application. In recalculating the risk to golfers to reflect the removal of fairways, the Agency also
applied the new transfer coefficient of 500. The resulting cancer risk estimate for adult golfers exposed
to tees and greens is 1.3xlO"6. The cancer risk estimate for golf course exposure assumes exposure to
the full amount applied, 18 times per year for 50 years. As indicated previously, a more realistic
estimate of the number of exposures to a golfer is two per year; when two exposures are assumed, the
resulting cancer risk estimate is 1.2xlO"7. When combined with the cancer risk from food, this results in
a cancer aggregate risk estimate of 2.8xlO"7, which is not of concern.
The estimated drinking water exposure from treated golf courses, including fairways, is 32.3 ppb. This
exceeds the cancer DWLOC of 1 ppb and is of concern. The estimated surface water EEC resulting
from use on tees and greens only, at the reduced application rate, assuming the maximum amount
applied and maximum frequency of application, is 5 ppb. Given the conservative assumptions on which
the EEC and DWLOC are based, the Agency does not believe that this represents a risk of concern.
This is discussed in greater detail above in the Section IV.E.l.d on mitigation of drinking water risks.
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4. Occupational Risk Mitigation
a. Handler Exposure
1) Overview
There are potential occupational exposures to pesticide handlers via the dermal and inhalation routes
when applying etridiazole. Scenarios assessed and corresponding risk estimates are shown in Table 9.
The footnotes indicate the level of protection (PPE or engineering controls) needed to bring the risk
estimate to a level that is not of concern (MOE of 100 or greater, and cancer risk of IxlO"6 or less). In
some cases these measures exceed what is specified on current labels. Risks for some scenarios are of
concern even when maximum PPE is applied, indicating a need for engineering controls. However, in
some of these scenarios, engineering controls are not available. Therefore, mitigation measures
necessary for etridiazole include a combination of increased PPE, use site deletions, prohibition of
hand-held spreaders, and reduced application rates. Specific measures are presented in greater detail
below.
Some uncertainty exists around inhalation toxicity and exposure for handlers and postapplication
workers. All margins of exposure were derived from PHED. The combined dermal and inhalation
MOEs were not significantly different from the dermal MOE, suggesting that occupational handler risks
are largely due to estimated dermal exposures. However, these MOEs are likely to underestimate
inhalation exposures. The vapor pressure of etridiazole is higher than the mean vapor pressure of
chemicals in PHED, so actual inhalation risks are expected to be higher than indicated by the calculated
inhalation MOEs. In addition, a chemical-specific postapplication exposure study in workers handling
treated potting soil found that approximately 70% of the total dose was due to inhalation. In calculating
inhalation risk estimates, the Agency used protective assumptions about the amounts handled and
number of exposures, and applied a 100% inhalation absorption factor.
The inhalation risk estimates indicate that an OV respirator provides the protection needed to bring
handler inhalation risk to a level that is not of concern. Therefore, the Agency has determined that,
unless closed systems are used, an OV respirator is necessary for all handlers for all uses except when
applying in-furrow to cotton. Due to the type of application, the Agency believes that inhalation risks to
handlers for in-furrow application are expected to be negligible. Current labels do not specify an OV
respirator, and the registrants have agreed to add this to the labels. Additional inhalation data are being
required as part of this RED, and are expected to confirm the current risk estimates.
EPA considers occupational cancer risks of IxlO"6 (1 in 1 million) and less to be negligible. In addition,
the Agency generally examines occupational risks in the range of IxlO"6 to IxlO"4 to determine the
feasibility and cost of additional mitigation and seeks ways to mitigate these risks. This policy allows for
the consideration of a wide range of factors in making a risk management decision for occupational
risks. These factors may include: risk to individuals, number of people exposed, weight of scientific
51
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evidence regarding carcinogenicity, and lower risk alternatives. EPA seeks to reduce the individual
risks to the greatest extent feasible, preferably to 1x10"6 or less. The goal is to ensure that there is a
minimum level of protection from exposure to pesticide for workers. Through the reregistration
process, the Agency will specify, as appropriate, additional protective clothing or equipment or changes
in application methods.
Current product labels vary widely in the amount of personal protection specified. The registrants have
agreed to the measures discussed in this document and labels will be amended accordingly. For some
products, the measures agreed to by the registrants represent an increase over what is currently on the
labels. For others, the level of protection necessary is less than that now on labels.
While the above discussion encompasses all uses of etridiazole, the remainder of the discussion on
mitigation measures will be presented by use site.
2) Cancelled Uses/Formulations
Flowable concentrate
To address risks associated with use of the flowable concentrate formulation, the registrant has
requested voluntary cancellation of this formulation. The Agency published the proposed cancellation
for public comment in the Federal Register on September 6, 2000 (Vol. 65, Number 173).
Granular formulation for use on golf courses
The registrants have agreed to remove fairway use from product labels immediately, limiting use of
etridiazole on golf courses to tees and greens. They have also agreed to explicitly state on product
labels that application of granulars with a push-type spreader, belly grinder, power dust blower or hand
dispersal is not allowed. The result is that no feasible application method for application of the granular
formulation to tees and greens remains. Therefore, the registrants have agreed to request a voluntary
cancellation of the granular formulation registered for use on golf course turf
1) Seed Treatment
All handlers
No chemical-specific data were available for assessing handler exposure for seed treatment use.
Uncertainties exist around dermal and inhalation exposure and toxicity of etridiazole. Inhalation
exposure is a particular concern when considering risks associated with indoor use. To address these
uncertainties, the registrant has agreed to specify closed systems for all seed treatment activities as well
as the use of chemical-resistant gloves and an OV respirator.
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1) Golf Course Use
All handlers
Mixing/loading wettable powder for groundboom application to golf course tees, greens and fairways
results in MOEs ranging from 7 to 87 and cancer risks between 10"4 and 10"5 with double-layer
clothing, chemical-resistant gloves, and organic-vapor (OV) respirator. The addition of engineering
controls results in MOEs of 100 or greater but cancer risks remain of concern.
To address these risks, the registrant has agreed to remove use on fairways from labels and to reduce
the maximum application rate, the frequency of application and the maximum poundage allowed to be
applied per season to tees and greens. These reductions result in intermediate-term MOEs of 102 and
95 and cancer risks of 10"5-10"7 with double-layer clothing, chemical-resistant gloves and an OV
respirator, which are not of concern.
To address cancer risks for mixing/loading wettable powder for chemigation for use on turf, the
registrant has agreed to specify double-layer clothing, chemical-resistant gloves and an OV respirator,
which results in MOEs greater than 100 and cancer risks of 10"6-10"7, which are not of concern.
To address risks associated with loading/applying granules to turf with a belly grinder (short-term
MOE of 35, intermediate-term MOE 13, cancer risks between 10"4 and 10"6) and push-type spreader
(short-term MOE of 53, intermediate-term MOE of 20, cancer risks between 10"4 and 10"6), the
registrant has agreed to request voluntary cancellation of the granular formulation for use on turf.
In summary, mitigation for all handlers for golf course use is as follows:
• Fairway use will be removed from product labels immediately.
• The maximum application rate will not exceed 3.8 Ibs ai/A.
• The interval between applications will be no less than 10 days.
• The maximum amount applied per season will not exceed 9.6 Ibs ai/A.
• Double-layer clothing, chemical-resistant gloves and an OV respirator are needed for all
handlers.
• Granular products registered for use on golf courses will be voluntarily cancelled.
5) Nursery (Outdoor) Use
Mining/loading/applying
For mixing/loading/applying EC in-furrow to nursery soil, chemical-resistant gloves are needed to
address short- and intermediate-term MOEs and cancer risks. The resulting MOEs are greater than
100 and cancer risks are 10"6-10"7, which are not of concern.
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For mixing/loading/applying EC as a drench with a low-pressure handwand, chemical-resistant gloves
are needed to address intermediate-term MOEs and cancer risks. The resulting MOEs are greater
than 100 and cancer risks are 10"7-10"8, which are not of concern.
For mixing/loading/applying EC as a drench with a high-pressure handwand, double-layer clothing,
chemical-resistant gloves and an OV respirator are needed to address cancer risks. The resulting
private cancer risk estimate is 10"6, while the commercial cancer risk estimate is 10"5, which is
acceptable in this case.
To address risks associated with mixing/loading/applying granules in-furrow to nursery soil, chemical-
resistant gloves and an OV respirator are needed for all handlers. The resulting MOEs are greater than
100 and cancer risks are less than 10"6.
To address risks associated with loading/applying granules with a belly grinder, power dust blower
and push-type spreader, the registrant has agreed to state on product labels that these application
methods are not allowed. With double-layer clothing, chemical-resistant gloves and an OV respirator,
short- and intermediate-term MOEs for these methods range from 3-15, and cancer risks are 10"4.
Loading/applying granules with a power dust blower could not be assessed because no data are
available for assessing this scenario. To address this uncertainty, the registrant has agreed to state on
product labels that this application method is not allowed. Applying granules by hand with double-
layer clothing, chemical-resistant gloves and an OV respirator results in margins of exposure of 13
(short-term) and 4.9 (intermediate-term) and cancer risks of 10"5. To address these risks, the registrant
has agreed to state on product labels that this application method is not allowed.
To address cancer risks for loading/applying granules (5% ai formulation) with a tractor-drawn
spreader at the maximum application rate, chemical-resistant gloves are needed. With gloves the
resulting cancer risks are 10"6. The registrants have agreed to reduce the granular application rate for
potting soil treatment to address postapplication cancer risks. This reduction will also reduce risks to
handlers. This reduction is discussed in greater detail below in the section on Postapplication Risk
Mitigation.
In summary, mitigation needed to address handler risks for nursery use:
EC formulation
For use with a high-pressure handwand, double-layer clothing, chemical-resistant gloves, and
an OV respirator are needed.
• For all other application methods, chemical-resistant gloves and an OV respirator are needed.
Granular formulation
Application by belly grinder, push-type spreader, power dust blower and by hand dispersal will
be explicitly not allowed on the labels.
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• For all handlers, chemical-resistant gloves and an OV respirator are needed.
6) Greenhouse/Potting Soil Use
Mining/loading/applying
To address uncertainties about indoor handler exposures, chemical-resistant gloves and an OV
respirator are needed for mixing/loading/applying granules to potting soil.
For mixing/loading/applying wettable powder to potting soil, chemical-resistant gloves and an OV
respirator are needed. The resulting MOEs are greater than 100 and cancer risks are 10"7.
In addition, continuous ventilation is needed during indoor handling of etridiazole or etridiazole-treated
media, including soil and water, as described in Section V.
In summary, mitigation needed for greenhouse use and use with potting soil are as follows:
All formulations
Chemical-resistant gloves and an OV respirator are needed for all handlers.
• Active continuous ventilation as described in Section V is needed for all indoor use.
7) Cotton Use
All Formulations
To address MOEs and cancer risks for mixer/loaders for in-furrow application of EC or granules to
cotton, chemical-resistant gloves and an OV respirator are needed. Resulting MOEs are greater than
100 and cancer risks are 10"6-10"7. For in-furrow applicators, only chemical-resistant gloves are
needed.
b. Post-Application Exposure
Postapplication worker risks associated with turf, seed treatment and cotton uses of etridiazole are not
of concern as long as the current REIs of 12 hours are retained.
For nursery and greenhouse workers handling treated potting soil, however, cancer risks based on
dermal and inhalation exposure are estimated to be 2.9 x 10"5 after 12 hours postapplication, and 6.0 x
10"5 after 24 hours postapplication. To mitigate this risk, the application rate for mixing granular
products with potting soil will be reduced to the lowest possible level that will still maintain efficacy of
the products. For the 3% granular, the maximum application rate will be reduced from 16 oz. per cubic
55
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yard to 12 oz. per cubic yard. The maximum application rate for the 5% granulars will be reduced
from 10 oz. per cubic yard to 8 oz. per cubic yard.
In addition, continuous mechanical ventilation is needed during all indoor postapplication work involving
etridiazole-treated media including soil and water, as described in Section V. Given this mitigation, the
current 12-hour REI for nursery and greenhouse use will be retained.
c. Dermal and Inhalation Toxicity and Exposure Uncertainties
The Agency is concerned about inhalation exposure to etridiazole, particularly in enclosed areas such as
greenhouses. Etridiazole has a relatively high vapor pressure, and the data from a chemical-specific
postapplication study indicate the majority of exposure to postapplication workers handling treated soil
was by the inhalation route. Further, this exposure is most likely to occur in a greenhouse where
inhalation hazards may be greater than outdoors. This, coupled with the lack of inhalation toxicity and
chemical-specific handler exposure data, raises concerns for both handlers and postapplication
workers. In addition, a chemical-specific subchronic dermal toxicity study and a dermal penetration
study would enable refinement of dermal risk estimates and help characterize cancer risks. The
Agency has used protective assumptions in its risk calculations including a 3x uncertainty factor applied
to the chronic NOAEL and 100% dermal and inhalation absorption factors. Thus, while the Agency
believes that the level of personal protection equipment including the organic-vapor respirator that has
been agreed to by the registrant adequately addresses handler risks, it is calling in additional data to
confirm these risk estimates.
The following confirmatory data are required:
• 830.7950 Vapor pressure (of the dry formulations, in order to determine if handling dry
formulations present a significant respiratory hazard)
870.3200 21-day dermal toxicity study
• 870.3465 28-day inhalation toxicity study
• 870.7600 Dermal penetration study in rats
875.1200 Guideline applicator study data for dermal exposure: indoors
875.1400 Guideline applicator study data for inhalation exposure: indoors
5. Environmental Risk Mitigation
a. Birds
In-furrow application to cotton presents no risk concerns for birds.
Turf use results in acute and chronic avian risks of concern, with RQs ranging from 0.1 to 64. The
deletion of fairway use results in an 88% reduction in area treated when compared with the current
56
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labeled use. In addition, the registrant has agreed to reduce the maximum application rate on tees and
greens, the frequency of application and the maximum amount applied per season. These restrictions
will mitigate both acute and chronic risks. Fairways provide more feeding opportunities for a variety of
bird species than do tees and greens; therefore, limiting use to tees and greens further mitigates avian
risks.
b. Mammals
In-furrow application to cotton presents no acute risk concerns for mammals.
For turf use, acute RQs range from 0 to 2.95. After one application at the typical application rate for
turf, there are acute risk concerns for small, intermediate and large mammals feeding on short grasses,
tall grasses, broadleaf plants and insects. After two and five applications at the typical application rate
for turf, there are acute risks for small, intermediate and large mammals feeding on short and tall grass,
broadleaf plants and insects. As indicated above, the Agency believes that the removal of fairway use
and reductions in maximum application rate, amount applied per season and frequency of application
will greatly reduce risk by minimizing exposure.
An assessment of chronic risks to mammals could not be conducted due to lack of appropriate toxicity
data. Chronic mammalian toxicity data that will enable this assessment are being required, as discussed
in Section V.A.1, Additional Generic Data Requirements, of this document.
c. Fish and Aquatic Invertebrates
Etridiazole is moderately toxic to both freshwater and marine fish and invertebrates. Available data
indicate that etridiazole produced chronic growth effects in freshwater fish.
Application to cotton presents no risk concerns for freshwater fish and invertebrates or for
estuarine/marine fish and invertebrates.
For turf use, the acute RQs for freshwater fish range from 0.188 to 0.361; chronic RQs range from
1.41 to 2.70. For freshwater invertebrates, acute RQs are 0.05 to 0.09; chronic RQs are 0.55 to
1.05. For estuarine/marine fish, acute RQs are 0.06 to 0.11. For estuarine/marine aquatic
invertebrates, acute RQs are 0.09 to 0.18. As indicated above, the Agency believes that the removal
of fairway use and reductions in maximum application rate, amount applied per season and frequency of
application will adequately address these risks. In addition, by prohibiting use on fairways, the fairways
themselves will act as buffer zones between treated tees/greens and surface water areas.
The degradate 3-DCMT was found to be very highly toxic to freshwater fish on an acute basis. No
toxicity data are available for the degradate 3-Carb-T; however, based on its partition coefficient, 3-
Carb-T is expected to be less toxic to aquatic organisms than 3-DCMT. Risk quotients were not
57
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calculated for the degradates due to a lack of data. Because the registrant has agreed to remove
fairway use from product labels, these data requirements are being held in reserve status at this time.
Should the Agency determine in the future that fairway use can be returned to product labels, acute
toxicity data for both degradates for estuarine/marine fish and invertebrates and freshwater fish and
invertebrates will be required.
d. Aquatic Plants
Etridiazole was classified as highly toxic to non-target aquatic plants. Toxicity to green algae was
approximately 100 times higher than other aquatic plants tested. Acute risk concerns exist at the typical
application rates for turf, with RQs ranging from 0.03 to 218. As indicated above, the Agency believes
that the removal of fairway use and reductions in the maximum application rate, amount applied per
season and frequency of application will greatly minimize the potential for exposure. In addition, by
prohibiting use on fairways, the fairways themselves will act as buffer zones between treated tees/greens
and surface water areas.
e. Summary of Environmental Risk Mitigation
These ecological risk estimates associated with turf use assume use on golf course tees, greens and
fairways. The registrant has agreed to delete fairway use from product labels, thereby reducing the
area treated by approximately 88%. In addition, they have agreed to reduce the maximum application
rate, the frequency of application, and the maximum amount applied per season. The registrant has
agreed to submit additional water data to refine these risk estimates. The Agency believes that removal
of fairway use from product labels in the interim period during which water data are developed is
appropriate to mitigate these risks.
Based on etridiazole's persistence and mobility, the following advisory language is needed for all
etridiazole product labels:
Surface Water Label Advisory
"Etridiazole can contaminate surface water through spray drift. Under some conditions, etridiazole may
also have a high potential for runoff into surface water for several weeks post-application. These
include poorly draining or wet soils with readily visible slopes toward adjacent surface waters,
frequently flooded areas, areas overlaying extremely shallow ground water, areas with in-field canals or
ditches that drain to surface water, areas not separated from adjacent surface waters with vegetated
filter strips, and areas overlaying tile drainage systems that drain surface water."
F. Other Label Statements
Other use and safety information needed for labeling of all end-use products containing etridiazole are
indicated in Table 15.
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1. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify pesticides whose
use may cause adverse impacts on endangered and threatened species, and to implement mitigation
measures that will eliminate the adverse impacts. At present, the program is being implemented on an
interim basis as described in a. Federal Register notice (54 FR 27984-28008, July 3, 1989), and is
providing information to pesticide users to help them protect these species on a voluntary basis. As
currently planned, but subject to change as the final program is developed, the final program will call
for label modifications referring to required limitations on pesticide uses, typically as depicted in county-
specific bulletins or by other site-specific mechanisms as specified by state partners. A final program,
which may be altered from the interim program, will be described in a future Federal Register notice.
The Agency is not imposing label modifications at this time through the RED. Rather, any requirements
for product use modifications will occur in the future under the Endangered Species Protection
Program..
2. Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead
Agencies for pesticide regulation and other parties to develop the best spray drift management
practices. Interim mitigation measures are necessary for aerial applications that should be placed on
product labels/labeling as specified in Section V of this document. The Agency has completed its
evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U.S.
pesticide registrants, and is developing a policy on how to appropriately apply the data and the
AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and
ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in
spray drift management practices to reduce off-target drift and risks associated with aerial as well as
other application types where appropriate. In the interim, the following spray drift related language is
needed.
For products that are applied outdoors in liquid sprays (except mosquito adulticides), regardless of
application method, the following must be added to the labels:
"Do not allow this product to drift"
3. For Commercial Use Only
Etridiazole is currently registered for use on golf course turf only; use on home lawns, sod farms and
municipal parks is prohibited. All product labels will be amended to state clearly "for commercial use
only."
59
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V. Actions Required of Registrants
A. Manufacturing Use Products
1. Water Exposure Data Requirements
As discussed previously in this document, estimated surface water concentrations of etridiazole were
derived from a Tier 1 screening-level model that is not intended for modeling concentrations after
application to turf. The registrant has agreed to submit, by March 31, 2001, refined estimates of
chronic surface water concentrations for etridiazole derived from a Tier 2 PRZM/EXAMS model
modified for turf applications. The adequacy of the model as well as the results of the modeling will be
considered together with the results of a repeat oncogenicity study in mice. If, after evaluation of the
results of both the water model and the oncogenicity study, the Agency believes that etridiazole residues
in surface water are not of concern, fairway use may be returned to product labels. If fairway use is
returned to product labels, ecotoxicity data on the degradates 3-Carb-T and 3-DCMT will be
required. The registrant has agreed to voluntarily cancel the fairway use if the Agency finds that the
risks remain of concern.
2. Additional Generic Data Requirements
The generic database supporting the reregistration of etridiazole for the eligible uses has been reviewed
and determined to be substantially complete. The following confirmatory data are required:
Guideline Test Name
U V/Visible Absorption
Directions for use
Foreign crop field trials (tomatoes)
Oncogenicity (mouse)
Dermal penetration in rats
21 -day dermal toxicity
28-day inhalation toxicity
Applicator dermal exposure: indoors
Applicator inhalation exposure: indoors
Estuarine/marine fish acute toxicity using the degradate 3-DCMT
OPPTS
Guideline No.
830.7050
860.1200
860.1500
870.4200
870.7600
870.3200
870.3465
870.1200
870.1400
850.1075
Old Guideline
No.
none
171-3
171-4(k)
83-2(b)
85-3
82-2
82-4
233
234
72-3(a)
60
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Guideline Test Name
Estuarine/marine invertebrate acute toxicity using the degradate 3-DCMT
Freshwater fish acute toxicity using the degradate 3-Carb-T
Freshwater invertebrate acute toxicity using the degradate 3-Carb-T
Freshwater invertebrate acute toxicity using the degradate 3-DCMT
OPPTS
Guideline No.
850.1035
850.1075
850.1010
850.1010
Old Guideline
No.
72-3(b)
72-1
72-2
72-2
Product Chemistry
Current directions for use and UV/visible absorption data are required for the 98.6% T/TGAI. In
addition, the registrants must either certify that the suppliers of beginning materials and the
manufacturing process for the etridiazole technical product have not changed since the last
comprehensive product chemistry review or submit a complete updated product chemistry data
package.
Residue Chemistry
Additional residue data, as outlined in the EPA import tolerance guidance document (HED SOP98-6),
are required reflecting the use of etridiazole on tomatoes grown outside of the United States in order to
reassess a tolerance for tomatoes. The registrant has expressed their intent to maintain a tolerance for
tomatoes, and has committed to submit the required data. Should the registrant decide against
submitting the required data, the current tolerance for tomatoes will be revoked.
Health Effects
There are several data gaps for the current Subdivision F Guideline requirements for a food-use
chemical (40 CFR Part 158.340). These include a repeat multigeneration reproduction study in rats
(protocol to include early thyroid measurements due to a concern for endocrine activity); a repeat
chronic toxicity study in dogs; and a repeat carcinogenicity study in mice. The requirement for
additional neurotoxic studies (i.e., delayed neurotoxicity study in the hen, acute neurotoxicity study,
subchronic neurotoxicity study and/or developmental neurotoxicity study) is placed in reserve status
pending submission and evaluation of a repeat multigeneration reproduction study in rats and a chronic
toxicity study in dogs.
A 28-day inhalation toxicity study in rats that assesses all the parameters required in the testing
guidelines for the 90-day inhalation study is required to provide inhalation toxicology endpoints for non-
cancer occupational and non-occupational inhalation risk assessment.
A 21-day dermal toxicity study in rats is required. In addition, a dermal penetration study in rats will
help to fully characterize dermal cancer risks.
61
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Indoor Applicator Exposure
Due to the relatively high vapor pressure of etridiazole and the data from the submitted soil handling
study that indicate the majority of soil handler exposure was by the inhalation route, the Agency is
concerned about handler exposure to etridiazole, particularly in enclosed areas such as greenhouses.
Therefore, the Agency is requiring product chemistry data on the vapor pressure of the dry formulations
in order to determine if handling dry formulations presents a significant respiratory hazard. In addition,
indoor dermal and inhalation handler exposure studies are required.
Environmental Fate and Ecological Effects
The environmental fate database for etridiazole is mostly complete, and adequate for risk assessment.
However, due to the lack of chronic mammalian toxicity data using the parent compound, a chronic risk
assessment for mammals could not be conducted. These data are required in order to fully characterize
risks to ecological resources.
Ecotoxicity data for the degradates 3-Carb-T and 3-DCMT for aquatic organisms were not available,
so risks associated with the degradates could not be assessed. Because the registrant has agreed to
remove fairway use from product labels, these data are not being required at this time. Should the
Agency determine in the future that fairway use can be returned to product labels, acute toxicity data
for both degradates for estuarine/marine and freshwater fish and invertebrates will be required.
3. Labeling for Manufacturing Use Products
To remain in compliance with FIFRA, manufacturing use product (MUP) labeling should be revised to
comply with all current EPA regulations, PR Notices and applicable policies. The MUP labeling should
bear the labeling contained in the table at the end of this section. The MUP label will explicitly prohibit
use of products that do not conform to Section V.B.2 of this document.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data regarding
the pesticide after a determination of eligibility has been made. Registrants must review previous data
submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct
new studies. If a registrant believes that previously submitted data meet current testing standards, then
the study MRID numbers should be cited according to the instructions in the Requirement Status and
Registrants Response Form provided for each product.
In order to more fully characterize exposure and risk to pesticide applicators due to inhalation when
handling the dry formulations of etridiazole (wettable powder, granular, dust), the Agency is requiring
vapor pressure data for the dry formulations.
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2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section V above. Specific language
to implement these changes is specified in Table 15 at the end of this section. The registrants have
agreed to submit, not later than November 17, 2000, a complete application for amendment of each of
the end-use products containing etridiazole for use on golf course fairways that are contained in
Appendix A of this document. Such application must indicate use on golf course tees and greens only,
and reflect all of the other mitigation measures agreed upon as indicated in this document. Should the
registrants fail to submit such application for any product currently registered for use on fairways within
the timeframe specified herein, the Agency may issue a Notice of Intent to Cancel that product. To
remain in compliance with FIFRA, end-use product (EUP) labeling should be revised to comply with all
current EPA regulations, PR Notices and applicable policies.
63
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C. Labeling Changes Summary Table
Table 15. Summary of Labeling Changes for Etridiazole
Description
Labeling Changes
Placement on Label
Manufacturing Use Products
Required on all MUPs
One of these statements
may be added to a label to
allow reformulation of the
product for a specific use or
all additional uses
supported by a formulator
or user group
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
Only for formulation into fungicide products intended for the following use(s): registrants insert
uses that are being supported by MP registrant] . " This product may not be formulated into
products intended for residential consumer use.
"This product may be used to formulate products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding
support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP
label if the formulator, user group, or grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans or
other waters unless in accordance with the requirements of a National Pollutant Discharge
Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to
discharge. Do not discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your state Water Board
or Regional Office of the EPA."
Directions for Use
Directions for Use
End Use Products Intended for Occupational Use (WPS and non-WPS)
Handler PPE for all
formulations
For sole-active-ingredient end-use products that contain etridiazole, the product labeling must be
revised to adopt the handler personal protective equipment/engineering control requirements set
forth in this section. Any conflicting PPE requirements on the current labeling must be removed.
For multiple-active-ingredient end-use products that contain etridiazole, the handler personal
protective equipment/engineering control requirements set forth in this section must be compared to
the requirements on the current labeling and the more protective must be retained. For guidance on
which requirements are considered more protective, see PR Notice 93-7.
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Table 15. Summary of Labeling Changes for Etridiazole
Description
Labeling Changes
Placement on Label
Handler PPE Requirements
for Wettable Powder
Formulations
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are [registrant inserts correct material]. For
more information, follow instructions in Supplement Three of PR Notice 93-7. If you want more
options, follow the instructions for category [insert A,B,C,D,E,F,G,or H] on an EPA chemical-
resistance category selection chart."
" Loaders, applicators, and other handlers involved in dry applications to potting soil must wear:
- long-sleeved shirt and long pants,
- socks and shoes,
- chemical-resistant gloves
- NIOSH-approved respirator with:
- an organic-vapor-removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or
- a NIOSH-approved respirator with an OV cartridge or canister with any N2, R, P or HE
prefilter
"All other mixers, loaders, applicators and handlers must wear:
- coveralls over long-sleeved shirt and long pants,
— chemical-resistant gloves,
- chemical-resistant footwear plus socks,
— NIOSH approved respirator with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or
- a NIOSH approved respirator with an OV cartridge or canister with any N2, R, P or HE prefilter"
— chemical-resistant apron when mixing, loading, cleaning equipment.
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
65
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Table 15. Summary of Labeling Changes for Etridiazole
Description
Labeling Changes
Placement on Label
Handler PPE requirements
for WP Formulations
(cont'd)
For use in tobacco floatbeds, application is continuous from the time this product is diluted and
pots or plant materials are immersed in the floatbeds through the time the pots or plant materials are
removed from the floatbeds and replanted. During the entire application period, any person who
contacts the floatbed, the diluted pesticide solution, treated pots, or treated plant materials is
defined as a handler under the Worker Protection Standard and must be trained as a handler and
wear the PPE required for handlers on the main Terrazole label. The 12-hour REI begins once the
plant materials are replanted.
Directions for Use for
the 24(c) Label
Handler PPE requirements
for Dust Formulations
"Mixers, loaders, and applicators must wear:
- coveralls over long-sleeved shirt and long pants,
— chemical-resistant gloves,
— NIOSH approved respirator with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G),
- or a NIOSH approved respirator with an OV cartridge or canister with any N2, R, P or HE
prefilter"
66
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Table 15. Summary of Labeling Changes for Etridiazole
Description
Labeling Changes
Placement on Label
Handler PPE Requirements
for Granular Formulations
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are [registrant inserts correct material]. For
more information, follow instructions in Supplement Three of PR Notice 93-7. If you want more
options, follow the instructions for category [insert A,B,C,D,E,F,G,or H] on an EPA chemical-
resistance category selection chart."
" Loaders, applicators and other handlers must wear:
- Long-sleeved shirt and long pants, and
- Socks and shoes
In addition, all handlers, except for applicators applying in-furrow to cotton, must wear:
— Chemical-resistant gloves, and
— NIOSH- approved respirator with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or
- a NIOSH approved respirator with an OV cartridge or canister with any N2, R, P or HE
prefilter"
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Table 15. Summary of Labeling Changes for Etridiazole
Description
Labeling Changes
Placement on Label
Handler PPE Requirements
for Liquid (EC)
Formulations1
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are [registrant inserts correct material]. For
more information, follow instructions in Supplement Three of PR Notice 93-7. If you want more
options, follow the instructions for category [insert A,B,C,D,E,F,G,or H] on an EPA chemical-
resistance category selection chart."
"Mixers, loaders, and applicators participating in high-pressure handwand sprayer applications
must wear:
- coveralls over long-sleeved shirt and long pants,
— chemical-resistant gloves,
- chemical-resistant footwear plus socks,
— chemical-resistant headgear for overhead applications,
— NIOSH approved respirator with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G),
- or a NIOSH approved respirator with an OV cartridge or canister with any N2, R, P or HE
prefilter"
— chemical-resistant apron when mixing, loading, or cleaning equipment.
"All other mixer, loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants,
— chemical-resistant gloves,
— NIOSH approved respirator (except for applicators applying in-furrow to cotton) with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or
- a NIOSH approved respirator with an OV cartridge or canister with any N2, R, P or HE
prefilter
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Table 15. Summary of Labeling Changes for Etridiazole
Description
User Safety Requirements
for EC and Wettable Powder
Formulations
User Safety Requirements
for Granular Formulations
Labeling Changes
"Discard clothing or other absorbent materials that have been drenched or heavily contaminated
with this product's concentrate. Do not reuse them."
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry. "
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry. "
Placement on Label
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
requirements
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
requirements
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Table 15. Summary of Labeling Changes for Etridiazole
Description
Labeling Changes
Placement on Label
Engineering Controls
"Engineering Controls"
"For all seed treatments, handlers must use a closed mixing, loading, and application system
designed by the manufacturer to enclose the pesticide in a manner that prevents it from contacting
(dermally or through inhalation) handlers or other people during the entire seed treatment process.
The system must be:
- entirely mechanized, so the only contact handlers have is with the unopened pesticide container
while they place it into the system, with the reclosed or empty container when it is removed from the
system, and with the bags containing the treated seed,
- functioning properly, and
- used and maintained in accordance with the manufacturer's written operating instructions.
Handlers participating in seed treatments must:
- wear the PPE required for handlers participating in seed treatments,
- wear protective eyewear, if the closed system operates under pressure, and
- be provided and have immediately available for use in an emergency, such as a spill or
equipment malfunction, coveralls, chemical-resistant footwear, and the type of respirator required
for handlers on this labeling."
"When all other handlers use closed systems or enclosed cabs in a manner that meets the
requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides (40 CFR
170.240(d)(5), the handler PPE requirements may be reduced or modified as specified in the WPS."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
following PPE and User
Safety Requirements.)
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the
toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and
put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing."
70
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
immediately following
Engineering Controls
(Must be placed in a
box.)
-------
Table 15. Summary of Labeling Changes for Etridiazole
Description
Labeling Changes
Placement on Label
Environmental Hazards
"Environmental Hazards"
"Do not apply directly to water, or to areas where water is present or to intertidal areas below the
mean high water mark. Do not contaminate water when cleaning equipment or disposing of
equipment washwaters."
Surface Water Advisory
"Etridiazole can contaminate surface water through spray drift. Under some conditions, etridiazole
may have a high potential for runoff into surface water for several weeks postapplication. These
conditions include poorly draining or wet soils with readily visible slopes toward adjacent surface
waters, frequently flooded areas, areas overlaying extremely shallow ground water, areas with in-
field canals or ditches that drain to surface water, areas not separated from adjacent surface waters
with vegetated filter strips, and areas overlaying tile drainage systems that drain surface water."
Precautionary
Statements under
Environmental Hazards
Restricted-Entry Interval
For WPS products as
required by Supplement
Three of PR Notice 93-7
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 12
hours."
"INDOOR RESTRICTIONS: Entry (including early entry that would otherwise be permitted under
the WPS) into greenhouses, potting sheds, and other indoor areas by any person — other than a
correctly trained applicator who is performing a handling task permitted by the WPS and who is
wearing the required handler PPE including a respirator — is PROHIBITED in the entire enclosed
structure/building from the start of application until application is complete and one of the following
ventilation criteria (providing outdoor air) is met: 10 air exchanges; (2) 2 hours of fans or other
mechanical ventilation providing outdoor air; (3)4 hours of vents, windows, or other passive
ventilation; (4) 11 hours with no ventilation followed by 1 hour of mechanical ventilation; (5) 11
hours of no ventilation followed by 2 hours of passive ventilation; or (6) 24 hours with no
ventilation. After ventilation criteria are met and until the REI expires, do not enter or allow worker
entry into treated areas, except as provided in the WPS. Note: after the expiration of the REI
whenever Terrazole-treated soil or planting media is being handled or disturbed indoors, continuous
ventilation of the area is required at a minimum rate of one complete air exchange per hour.
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Table 15. Summary of Labeling Changes for Etridiazole
Description
Entry Restriction for non-
WPS uses applied as a
spray:
Entry Restriction for non-
WPS uses applied dry:
Early Re-entry Personal
Protective Equipment for
Products subject to WPS as
required by Supplement
Three of PR Notice 93-7.
Application Restrictions
Labeling Changes
"Do not enter or allow others to enter until sprays have dried.
"Do not enter or allow others to enter until dusts have settled."
"PPE required for early entry to treated areas that is permitted under the Worker Protection Standard
and that involves contact with anything that has been treated, such as soil or water, is:"
For all end-use products:
- Coveralls
— Chemical-resistant gloves such as or made out of any waterproof material
— Shoes plus socks
"Do not apply this product in a way that will contact workers or other persons, either directly or
through drift. Only protected handlers may be in the area during application."
"Do not allow this product to drift."
Placement on Label
Place in the Direction
for Use directly above
the Agricultural Use
Box.
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Table 15. Summary of Labeling Changes for Etridiazole
Description
Labeling Changes
Placement on Label
Other Use/Application
Restrictions.
Labels must be modified to reflect the following restrictions:
The maximum application rate for golf course tees and greens may not exceed 3.8 Ibs. ai/A per
application.
The maximum amount applied to golf course tees and greens may not exceed 9.6 Ibs ai/A per year.
The interval between application to golf course tees and greens may not be less than 10 days.
"Application to golf course turf is limited to tees and greens. Application to fairways is prohibited."
"Application by hand-held broadcast spreader (belly grinder), push-type spreader, power dust
blower, and dispersal by hand is prohibited." (This only applies to formulations applied dry)
"For dry soil mix, the maximum application rate for 3% ai granular products may not exceed 12
oz./cu.yd."
"For dry soil mix, the maximum application rate for 5% ai granular products may not exceed 8
oz./cu.yd."
"For commercial use only. Not for use on home lawns, sod farms, or municipal parks."
"For use in commercial greenhouses only. Use in residential greenhouses or other indoor plant
sites is prohibited."
Directions for Use
under General
Precautions and
restrictions and/or
Applications
Instructions
'PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be
placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
2If the product contains oil or bears instructions that will allow application with an oil-containing material, the "N" designation must be dropped. Instructions in the Required
Labeling section appearing in quotations represent the exact language that must appear on the label.
73
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D. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26 months from the
date of the issuance of this Reregistration Eligibility Decision (RED). Persons other than the registrant
may generally distribute or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors. Refer to "Existing Stocks of
Pesticide Products; Statement of Policy"; Federal Register., Volume 56, No. 123, June 26, 1991.
For etridiazole products registered for use on golf course turf:
The Agency and registrants have agreed that the registrants may distribute and sell the etridiazole end-
use products bearing old labels/labeling until March 31, 2001. Registrants and persons other than
registrants remain obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
For etridiazole products except those registered for use on golf course turf:
The Agency has determined that registrants may distribute and sell etridiazole products bearing old
labels/labeling for 26 months from the date of issuance of this RED. Persons other than the registrant
may distribute or sell such products for 50 months from the date of the issuance of this RED.
Registrants and persons other than registrants remain obligated to meet pre-existing Agency imposed
label changes and existing stocks requirements applicable to products they sell or distribute.
74
-------
75
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VI. Appendices
76
-------
Appendix A. Use Patterns Eligible for Reregistration
Site
Application Type
Formulation
[EPA Reg. No.]
Max. Single Application
Rate
Restricted
Entry
Interval
Plantback Interval3
Preharvest
Interval
Use Limitations15
FOOD/FEED USES
Barley, Peas, and Soybean
Seed treatment
5% D [750 1-54]
5. 8% RTU [750 1-57]
5.8% EC [34704-679]
0.0125 Ib. ai/bu
0.0145 Ib. ai/bu
0.0145 Ib. ai/bu
12 hours
120 days: root crops
30 days: leafy vegetables,
small grains, other rotated
crops
NA
Treated seed must not be
used for or mixed with food
or animal feed, or
processed for oil.
Beans
Seed treatment
Corn and Sorghum
Seed treatment
5%D [7501-54]
5. 8% RTU [750 1-57]
5.8% EC [34704-679]
5% D [750 1-54]
5. 8% RTU [750 1-57]
5.8% EC [34704-679]
0.00625 Ib. ai/bu
0.00725 Ib. ai/100 Ib. seed
0.00725 Ib. ai/bu
0.0125 Ib. ai/100 Ib. seed
0.00725 Ib. ai/100 Ib. seed
0.00725 Ib. ai/100 Ib. seed
12 hours
12 hours
120 days: root crops
30 days: leafy vegetables,
small grains, other rotated
crops
120 days: root crops
30 days: leafy vegetables,
small grains, other rotated
crops
NA
NA
Treated seed must not be
used for or mixed with food
or animal feed, or
processed for oil.
Treated seed must not be
used for or mixed with food
or animal feed, or
processed for oil.
Cotton
Seed treatment
5% D [750 1-54]
5. 8% RTU [750 1-57]
5. 8% EC [34704-679]
0.05 Ib. ai/100 Ib. seed
0.058 Ib. ai/100 Ib. seed
0.058 Ib. ai/100 Ib. seed
12 hours
120 days: root crops
30 days: leafy vegetables,
small grains, other rotated
crops these crops.
NA
Treated seed must not be
used for or mixed with food
or animal feed, or
processed for oil.
77
-------
Site
Application Type
In-furrow
at-planting
Formulation
[EPA Reg. No.]
1. 63% G [400-408]
2. 5% G [400-406]
2.5% G [264-319]
3. 8% G [400-456]
4. 3% EC [400-475]
5. 8% EC [400-405]
44.3% EC [400-422]
Max. Single Application
Rate
0.3 Ib. ai/A
0.3 Ib. ai/A
0.375 Ib. ai/A
0.38 Ib. ai/A
0.275 Ib. ai/A
0.37 Ib. ai/A
0.2215 Ib ai/A
Restricted
Entry
Interval
12 hours
Plantback Interval3
120 days: root crops
30 days: leafy vegetables,
small grains and other
rotated crops
Preharvest
Interval
NA
Use Limitations'5
Apply only at planting.
Cotton foliage may not be
used for livestock feed.
Do not use with cotton
seed previously treated
with etridiazole.
Peanuts
Seed treatment
2.5%D [7501-111,
7501-153]
5% D [750 1-54]
5. 8% RTU [750 1-57]
5. 8% EC [34704-679]
0.009 Ib. ai/100 Ib. seed
0.0125 Ib. ai/100 Ib. seed
0.0145 Ib. ai/100 Ib. seed
0.0145 Ib. ai/100 Ib. seed
12 hours
120 days: root crops
30 days: leafy vegetables,
small grains, other rotated
crops
NA
Treated seed must not be
used for or mixed with food
or animal feed, or
processed for oil.
Safflower
Seed treatment
5% D [750 1-54]
5. 8% RTU [750 1-57]
5. 8% EC [34704-679]
0.0125 Ib. ai/100 Ib. seed
0.0145 Ib. ai/100 Ib. seed
0.0145 Ib. ai/100 Ib. seed
12 hours
120 days: root crops
30 days: leafy vegetables,
small grains, other rotated
crops
NA
Treated seed must not be
used for or mixed with food
or animal feed, or
processed for oil.
Wheat
Seed treatment
5% D [750 1-54]
5. 8% RTU [750 1-57]
5.8% EC [34704-679]
0.00625 Ib. ai/bu
0.00625 Ib. ai/bu
0.00725 Ib. ai/bu
12 hours
120 days: root crops
30 days: leafy vegetables,
small grains, other rotated
crops
NA
Treated seed must not be
used for or mixed with food
or animal feed, or
processed for oil.
78
-------
Site
Application Type
Formulation
[EPA Reg. No.]
Max. Single Application
Rate
Restricted
Entry
Interval
Plantback Interval3
Preharvest
Interval
Use Limitations15
NON-FOOD/FEED USES
Non-Bearing Citrus
Containerized
seedlings, liners
40% WP [58185-10]
0.3 Ib. ai/400 s.f.
12 hours
NA
2 years
Non-bearing Coffee
Seedlings
(propagation)
40% WP [58185-10]
0.083 Ib. ai/s.y.
12 hours
NA
2 years
Golf Course Turf
Tees, greens,
fairways
30% EC [58 185-5]
35% WP [400-416]
30% WP [58185-7]
3.8 Ib. ai/A
3.8 Ib. ai/A
3.8 Ib. ai/A
12 hours
NA
NA
Maximum amount applied
per season may not exceed
9.6 Ibs ai/acre. Interval
between applications may
not be less than 10 days.
Ornamentals
Shade trees,
herbaceous
plants,
nonflowering
plants, woody
shrubs and vines
soil drench,
side-dress
3% G [58185-23]
5% G [58185-13]
25% EC [400-417]
25% EC [58 185-8]
30% WP [58185-7]
35% WP [400-416]
40% WP [58185-10]
44.3% EC [400-422]
0.01 lib. ai/lin. ft.
0.0125 Ib. ai/100 lin. ft.
0. 125 Ib. ai/400 s.f.
0. 125 Ib. ai/400 s.f.
0.225 Ib. ai/400 s.f.
0. 175 Ib. ai/400 s.f.
0.3 Ib. ai/400 s.f.
0.11 llb./400 s.f.
12 hours
NA
NA
Application with hand-held
or push-type equipment,
power dust blower and by
hand is prohibited.
79
-------
Site
Application Type
Shade trees,
herbaceous
plants,
nonflowering
plants, woody
shrubs and vines
dry soil mix
Formulation
[EPA Reg. No.]
3% G [58185-23]
5% G [400-419, 58185-
13]
30% WP [58185-7]
Max. Single Application
Rate
0.0225 Ib./c.y.
0.025 Ib./c.y.
0.05625/c.y.
Restricted
Entry
Interval
12 hours
Plantback Interval3
NA
Preharvest
Interval
NA
Use Limitations15
Application with hand-held
or push-type equipment,
power dust blower and by
hand is prohibited.
Tobacco
transplant float
beds
35% WP [400-416]
0.7 Ib./lOO gal.
12 hours
NA
NA
see Table 1 5 for details
aPlantback intervals are based on etridiazole rotational crop study and apply only to etridiazole. For products containing multiple active ingredients, plantback
intervals for all active ingredients must be compared and the most protective interval will be applied.
bRefer to Table 15 of the Reregistmtion Eligibility Document for additional use restrictions.
Formulation Codes
D: Dust
EC: Emulsifiable concentrate
G: Granular
RTU: Liquid ready-to-use
WP: Wettable powder
Unit Descriptions
ai/bu: active ingredient per bushel
ai/A: active ingredient per acre
s.f: square feet
lin. ft.: linear feet
c.y.: cubic yards
s.y.: square yards
80
-------
81
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Etridiazole
GUIDE TO APPENDIX B
Appendix B contains a listing of data requirements which support the reregistration for active
ingredients within the case covered by this RED. It contains generic data requirements that apply
etridiazole in all products, including data requirements for which a "typical formulation" is the test
substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR part 158. The reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidance, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-
4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this column
lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRID number has been assigned. Refer to
the Bibliography appendix for a complete citation of the study.
82
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Etridiazole
New
Guideline
Number
Old Guideline
Number
Requirement
Use
Pattern
Citation(s)
Product Chemistry
830.1550
830.1600
830.1620
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
61-1
61-2(a)
158.162
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-13
63-14
63-15
63-16
63-17
63-19
Product identity and composition
Beginning materials and manufacturing process
Description of production process
Formation of impurities
Preliminary analysis
Certification of limits
Analytical method
Color
Physical state
Odor
Stability
Oxidizing/reducing action
Flammability
Explodability
Storage stability
Miscibility
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
43597401
00001553,42912201
00001553,42912201
42912202
00158120, 42912203, 43597401
42912204
00158120, 42912203, 43597401
00001553
00001553
00001553
00001553,42912210,42912211,
42912212
42912213
00001553
00062469
00001553,43232001
00062469
83
-------
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Etridiazole
New
Guideline
Number
830.6320
830.7000
830.7050
830.7100
830.7220
830.7300
830.7370
830.7550
830.7840
830.7860
830.7950
Old Guideline
Number
63-20
63-12
none
63-18
63-6
63-7
63-10
63-11
63-8
63-9
Requirement
Corrosion characteristics
PH
UV/Visible absorption
Viscosity
Boiling point
Density
Dissociation constant
Octanol/water partition coefficient
Solubility
Vapor pressure
Use
Pattern
all
all
all
all
all
all
all
all
all
all
Citation(s)
00001553,43232002
00001553
Data gap
42912214
00001553
00001553
42912209
42515901
00001553, 00001644, 42912205,
42912206,42912207
00001553,42912208
Environmental Fate
835.1240
835.1410
835.1850
835.2120
835.2410
835.4100
163-1
163-2
165-1
161-1
161-3
162-1
Leaching/adsorption/desorption
Volatility - laboratory
Confined rotational crop
Hydrolysis
Photodegradation - soil
Aerobic soil metabolism
ABCI
ABI
AB
ABCIM
AB
ABCI
43504302, 43504303, 43504304
43024101
44311401
00001650
43124301
43504301
84
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Etridiazole
New
Guideline
Number
835.4400
835.6100
850.1730
Old Guideline
Number
162-3
164-1
165-4
Requirement
Anaerobic aquatic metabolism
Terrestrial field dissipation
Bioaccumulation in fish
Use
Pattern
ABI
ABC
ABC
Citation(s)
43504305
44864901,
44689601 (supplemental), 44689602,
44689603
43241401
Ecological Effects
850.1010
850.1035
850.1055
850.1075
850.1075
850.1075
850.1400
850.2100
850.2200
72-2(a)
72-3(c)
72-3(b)
72-l(b)
72-l(d)
72-3(a)
72-4(a)
71-1
71-2(a)
Invertebrate toxicity
Estuarine/marine toxicity - shrimp
Estuarine/marine toxicity - mollusk
Fish toxicity - bluegill sunfish
Fish toxicity - rainbow trout
Estuarine/marine toxicity - fish
Early life stage - fish
Avian acute oral toxicity
Avian dietary toxicity - quail
ABCIM
ABC
ABC
ABCIM
ABCIM
ABC
ABC
ABCIM
ABCIM
Data gap
00062427 (supplemental)
42834603
42834602 (supplemental)
0001773,
00001572 (supplemental)
0001773,
00001572 (supplemental), 44606702
42834601
42834604 (supplemental)
42834605
00002238,
00003276 (supplemental)
00062478 (supplemental), 00062479
(supplemental)
85
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Etridiazole
New
Guideline
Number
850.2300
850.2300
850.4400
Old Guideline
Number
71-4(a)
71-4(a)
122-2
Requirement
Avian reproduction - quail
Avian reproduction - duck
Aquatic plant growth
Use
Pattern
ABC
ABC
C
Citation(s)
43744101 (supplemental), 4371 5601
43744102 (supplemental), 43744103
42834606, 42834607, 42834608,
42834609, 42834610 (supplemental)
Residue Chemistry
860.1300
860.1300
860.1340
860.1340
860.1360
860.1380
860.1500
860.1520
171-4(a)
171-4(b)
171-4(c)
171 -4(d)
171-4(m)
171-4(e)
171 -4(k)
171-4(1)
Nature of residue - plants
Nature of residue - livestock
Residue analytical method - plants
Residue analytical method - livestock
Multiresidue methods
Storage stability
Crop field trials (cottonseed)
Processed food/feed (cottonseed)
ABM
ABM
ABM
ABM
AB
AB
AB
AB
00001689, 00028419, 00093751,
43940001, 44054701, 44285200,
44453201
00093753, 00093754
00001570, 00001645, 00002229,
00002239, 00002257, 00028423,
00028424, 00028428, 00014333,
00093752,00139669
00001695, 00093752, 00093755
43259601
00093754, 00093755, 44285001,
43305701
00014318, 00028427, 00064191,
00064194,44285901
00093755, 00093756, 00093747,
00093748,44285901
Toxicology
86
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Etridiazole
New
Guideline
Number
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3150
870.3200
870.3700
870.3700
870.3800
870.4100
870.4200
870.4200
870.5100
870.5300
Old Guideline
Number
81-1
81-2
81-3
81-4
81-5
81-6
82-l(a)
82-l(b)
82-2(b)
83-3(a)
83-3(b)
83-4
83-l(b)
83-2(a)
83-2(b)
84-2
84-2
Requirement
Acute oral toxicity - rat
Acute dermal toxicity - rabbit
Acute inhalation toxicity - rat
Primary eye irritaton - rabbit
Primary dermal irritation - rabbit
Dermal sensitization
90-day oral toxicity - rodent
90-day oral toxicity - dog
21/28-day dermal toxicity - rabbit
Developmental toxicity - rat
Developmental toxicity - rabbit
Multigeneration reproduction toxicity - rat
Chronic oral toxicity - dog
Oncogenicity - rat
Oncogenicity - mouse
Gene mutation - S. typhimurium and E. coli
Gene mutation/in vitro mammalian cell assay in Chinese hamster ovary
cells
Use
Pattern
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
ABCIM
Citation(s)
43724501
43724502
43724503
43724504
43724505
43724506
Data gap
Data gap
Data gap
00120415
00104999
Data gap
Data gap
40747901
Data gap
Data gap; 00073206
00093743
87
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Etridiazole
New
Guideline
Number
870.5385
870.5900
870.53757
870.5900
870.7485
Old Guideline
Number
84-2(b)
84-2
84-2
85-1
Requirement
CytogeneticsAw vivo mouse micronucleus assay
Other mutagenic mechanisms/i'w vitro sister chromatid exchange in
Chinese hamster ovary cells
Other mutagenic mechanismsAw vitro cytogenetics/sister chromatid
exchange in Chinese hamster ovary cells
Metabolism - rat
Use
Pattern
ABCIM
ABCIM
ABCIM
ABCIM
Citation(s)
41837501
00120414
00120416
43654801
Occupational and Residential Exposure
875.1100
875.1300
875.2100
875.2200
875.2400
875.2500
231
232
132-1 (a)
132-l(b)
133-3
133-4
Estimation of dermal exposure - outdoor (applicator)
Estimation of inhalation exposure - outdoor (applicator)
Foliar residue dissipation (postapplication)
Soil residue dissipation (postapplication)
Dermal passive dosimetry (postapplication)
Inhalation passive dosimetry (postapplication)
ABC
ABC
ABC
ABC
ABC
ABC
43717901,
43666001 (supplemental)
43717901,
43666001 (supplemental)
43287801 (supplemental), 43287802
(supplemental)
44227801 (supplemental),
43287801 (supplemental), 43287802
(supplemental)
44227801 (supplemental),
43287801 (supplemental), 43287802
(supplemental)
44227801 (supplemental)
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, located in Room
119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through
Friday, excluding legal holidays, from 8:30 am to 4 pm.
The following documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at: www.epa.gov/pesticides/op
General
Overview of Preliminary Etridiazole (Terrazole®) Risk Assessment
Etridiazole (Terrazole®) Summary
Quantitative Usage Analysis for Etridiazole, June 15, 1999
Response to Registrant's 30-Day Comments on the Preliminary Risk Assessments, June 5, 2000
Notes of the Terrazole Mitigation Discussion, May 23, 2000
Human Health Assessment
Revised Human Health Risk Assessment, June 6, 2000
Appendices to the Health Effects Assessment, June 6, 2000
Report of the Hazard Identification Assessment Review Committee (HLARC), June 29, 1999
Report of the Hazard Identification Assessment Review Committee (HIARC), Requirement of a
Carcinogenicity Study in a Second Species, the Mouse, July 26, 2000
HLARC Revisit to Estimate the Percentage (%) Dermal Absorption of the Fungicide, Terrazole,
July 27, 2000
Report of the FQPA Safety Factor Committee, June 3, 1999
Acute and Chronic (Cancer and Non-Cancer) Dietary Exposure Analyses, November 29, 1999
Product and Residue Chemistry Chapters, November 17, 1999
Toxicology Chapter, December 23, 1999
Revised Toxicology Chapter, September 13, 2000
Revised Occupational and Residential Exposure Assessment, June 5, 2000
Ecological Risk Assessment
Revised Environmental Risk Assessment, May 22, 2000
Appendices to the Environmental Risk Assessment
Refined Tier 1 Chronic Surface Water EECs for Use in the Human Health Drinking Water Risk
Assessment, May 26, 2000
89
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Appendix D. Citations Considered to Be Part of the Data Base Supporting the
Reregistration Eligibility Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered
relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration
Eligibility Document. Primary sources for studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections
from other sources including the published literature, in those instances where they have been
considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The Agency
has also attempted to unite basic documents and commentaries upon them, treating them as a single
study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and should be
used whenever a specific reference is required. It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the review
may be preceded by a nine character temporary identifier. These entries are listed after all MRID
entries. This temporary identifying number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a
citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the standard of
the American National Standards Institute (ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show a
personal author. When no individual was identified, the Agency has shown an identifiable
laboratory or testing facility as the author. When no author or laboratory could be identified,
the Agency has shown the first submitter as the author.
90
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b. Document date. The date of the study is taken directly from the document. When the date is
followed by a question mark, the bibliographer has deduced the date from the evidence
contained in the document. When the date appears as (1999), the Agency was unable to
determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance
a document title. Any such editorial insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text) the following elements describing the earliest
known submission:
(1) Submission date. The date of the earliest known submission appears immediately following
the word "received."
(2) Administrative number. The next element immediately following the word "under" is the
registration number, experimental use permit number, petition number, or other
administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing parentheses
identifies the EPA accession number of the volume in which the original submission of the
study appears. The six-digit accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by an alphabetic suffix
which shows the relative position of the study within the volume.
91
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92
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104
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Appendix E. Generic Data Call-In
See the following table for a list of generic data requirements. Note that a complete Data Call-in
(DCI), with all pertinent instructions, is being sent to registrants under separate cover.
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Appendix F. Product-Specific Data Call-In
See attached table for a list of product-specific data requirements. Note that a complete Data Call-
in (DCI), with all pertinent instructions, is being sent to registrants under separate cover.
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Product Specific DATA CALL-IN RESPONSE page 1 of 1
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Product Specific REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE page 1 of 2
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Requirements Status And Registrant's Response Page 2 of 2
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Product Specific Footnotes and Key Definitions for Guideline Requirements
Page 1 of2
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Product Specific Footnotes and Key Definitions for Guideline Requirements Page 2 of 2
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Appendix G. EPA's Batching of Etridiazole Products for Meeting Acute Toxicity Data
Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for reregistration of products containing etridiazole (Terrazole®) as the primary
active ingredient, the Agency has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification,
precautionary labeling, etc.). Note the Agency is not describing batched products as "substantially
similar" since some products with in a batch may not be considered chemically similar or have identical
use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
battery of six acute lexicological studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within in a batch, or to generate all the required acute
toxicological studies for each of their own products. If the registrant chooses to generate the data for a
batch, he/she must use one of the products within the batch as the test material. If the registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the data
base is complete and valid by to-days standards (see acceptance criteria attached), the formulation
tested is considered by EPA to be similar for acute toxicity, and the formulation has not been
significantly altered since submission and acceptance of the acute toxicity data. Regardless of whether
new data is generated or existing data is referenced, the registrants must clearly identify the test material
by EPA Registration Number. If more than one confidential statement of formula (CSF) exists for a
product, the registrant must indicate the formulation actually tested by identifying the corresponding
CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days of
receipt. The first form, "Data Call-in Response, " asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response,"
lists the product specific data required for each product, including the standard six acute toxicity tests.
A registrant who wishes to participate in a batch must decide whether he/she will provide the data or
depend on someone else to do so. If the registrant supplies the data to support a batch of products,
he/she must select the one of the following options: Developing data (Option 1), Submitting an existing
Study (Option 4), Upgrading an existing Study (Option 5), or Citing an Existing Study (Option ). If a
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registrant depends on another's data, he/she must choose among: Cost sharing (Option 2), Offers to
Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to
participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that
choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her
studies and offering to cost share (Option 3) those studies.
Twenty seven products were found which contain Terrazole as the active ingredient. These
products have been placed into six batches and a "No Batch" category in accordance with the active
and inert ingredients and type of formulation.
Batch 1
EPA Reg. No.
400-423
58185-19
58185-20
Percent Active Ingredients
43.0
40.0
40.0
Formulation Type
Liquid
Liquid
Liquid
Batch 2
EPA Reg. No.
400-416
58185-5
58185-7
Percent Active Ingredients
35.0
32.3
30.0
Formulation Type
Solid
Solid
Solid
Batch 3
EPA Reg. No.
400-417
58185-8
Percent Active Ingredients
25.0
25.0
Formulation Type
Liquid
Liquid
Note: Formulations in Batch 4 may be cited to support acute toxicity data for product in Batch
4a.
Batch 4
Batch 4a
EPA Reg. No.
400-419
58185-13
58185-16
Percent Active Ingredients
5.35
5.0
1.3
Formulation Type
Solid
Solid
Solid
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Note: Formulations in Batch 5 may be cited to support acute toxicity data for product in Batch
5a.
Batch 5
Batch 5a
EPA Reg No.
400-405
34704-679
400-455
Percent Active Ingredients
5.8 Terrazole
23.0 PCNB
5.8 Terrazole
23.0 PCNB
5.8 Terrazole
23.0 PCNB
Formulation Type
Liquid
Liquid
Liquid
Batch 6
EPA Reg. No
7501-111
7501-153
Percent Active Ingredients
2.5 Terrazole
10.0 PCNB
18.75 Maneb
IS.OOCaptan
2.5 Terrazole
10.0 PCNB
18.75 Maneb
IS.OOCaptan
Formulation Type
Solid
Solid
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Note: EPA Reg. No. 400-456 may be cited to bridge acute toxicity data for EPA Reg. No. 400-406.
No Batch
EPA Reg. No.
264-319
400-408
400-475
58185-10
400-413
400-422
400-406
400-456
7501-54
58185-23
7501-57
Percent Active Ingredients
2.5 Terrazole
5.0 Aldicarb
10.0PCNB
1 .63 Terrazole
6.5 PCNB
6.5 Disulfoton
4.3 Terrazole
17.5 PCNB
17.5 Disulfoton
15.0 Terrazole
25.0 Thiophanate-methyl
98.6 Terrazole
44.0 Terrazole
2.5 Terrazole
10.0 PCNB
3.86 Terrazole
15.0 PCNB
5.8 Terrazole
25.0 PCNB
3.0 Terrazole
5.0 Thiophanate-methyl
5.8 Terrazole
23.0 PCNB
Formulation Type
Solid
Solid
Liquid
Solid
Liquid
Liquid
Liquid
Solid
Solid
Solid
Liquid
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Appendix H. List of Registrants Sent This Data Call-In Notice
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Appendix I. Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet
site:
http ://www. epa. gov/opprdOO 1 /forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703)
308-5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee
Filing
httD://www. eDa.gov/ODDrd001/forms/8570-l.pdf.
httD://www.eDa.gov/ODDrd001/forms/8570-4.pdf.
http://www.epa.aov/opprd001/forms/8570-5.pdf.
httD://www.eDa. gov/ODDrdOO l/forms/8570- 1 7.pdf.
httD://www.eDa.gov/ODDrd001/forms/8570-25.pdf.
http://www.epa.gov/opprd001/forms/8570-27.pdf.
httD://www.eDa.gov/ODDrd001/forms/8570-28.Ddf.
httD://www.eDa.gov/ODDrd001/forms/8570-30.pdf.
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8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of
Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical
Properties (in PR Notice 98- 1 )
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.aov/opprd001/forms/8570-32.pdf.
http://www.epa.aov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR_Notices/pr98-5.pdf.
httD://www.eDa.aov/ODDDmsdl/PR Notices/pr98-l .pdf.
httD://www.eDa.aov/ODDDmsdl/PR Notices/Dr98-l .pdf.
Pesticide Registration Kit
Dear Registrant:
www.epa.gov/pesticides/registrationkit/.
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug
and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in
PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will require
the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
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d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader.)
a. Registration Division Personnel Contact List
2. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional sources of
information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United States",
PB92-221811, available through the National Technical Information Service (NTIS) at the
following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting from the
passage of the FQPA and the reorganization of the Office of Pesticide Programs. We anticipate
that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at
(800) 858-7378 or through their Web site: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
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encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide the
EPA identifying File Symbol or petition number for the new submission. The identifying number
should be used whenever you contact the Agency concerning an application for registration,
experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind" codes
used when a sample was submitted for testing by commercial or academic facilities). Please
provide a CAS number if one has been assigned.
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